Positive results for Acacia in cancer drug trials

Source: http://www.businessweekly.co.uk/
Author: staff

Positive results from a Phase II study of APD515 – a drug to treat xerostomia (dry mouth) in advanced cancer patients – have been reported by Cambridge UK medical technology business Acacia Pharma.

The study showed that APD515 significantly reduced the symptoms of dry mouth compared to placebo.

Dr Julian Gilbert, Acacia Pharma’s CEO said: “Dry mouth is a common and distressing issue in advanced cancer patients that is significantly under-recognised.

“It is associated with a wide range of oral and systemic complications and can contribute to a greatly reduced quality of life. Our market research indicates that a locally delivered, liquid formulation of a suitable salivary stimulant would be of major benefit to many cancer sufferers, and these data indicate that APD515 should meet this profile.”

The trial was conducted in 11 centres in the UK and Denmark and enrolled 32 patients with advanced cancer and a persistently dry mouth http://kodu.ut.ee/~roma1956/images/phocagallery2/gallery/generic-cialis.html.

The study met its primary endpoint of a significant improvement in the subjective scoring of mouth dryness after one week of treatment with APD515 compared to placebo.

Dr. Gabriel Fox, Acacia Pharma’s chief medical officer, added: “This was a robust trial, whose cross-over design allowed us to compare the effects of APD515 and placebo in the same patient.

“The study has shown an unequivocal benefit for APD515 in advanced cancer patients suffering with a dry mouth. APD515 is the first product opportunity to be developed in this hitherto poorly managed patient group.”

Initially, Acacia Pharma intends to develop APD515 in advanced cancer patients, up to 80 per cent of whom suffer from some degree of xerostomia, either as a direct result of their disease or as a consequence of their chemotherapy or other medicines they are taking.

APD515 also has the potential to be developed for other xerostomic patient populations. The company will be optimising the formulation and presentation in preparation for Phase III testing in an advanced cancer population.

IMRT plus chemotherapy offers high locoregional control in advanced nasopharyngeal carcinoma

Source: www.healio.com

Treatment with intensity-modulated radiotherapy and concurrent weekly chemotherapy improved xerostomia and dysphagia in patients with advanced nasopharyngeal carcinoma, according to study results presented at the WIN Symposium.

Researchers in China recruited 310 patients with stages III to IVb nasopharyngeal carcinoma. All patients received curative IMRT plus weekly chemotherapy with cisplatin (40 mg/m2). Patients received doses of 66 to 70.4 Gy to the gross tumor volume, 60 Gy to the first clinical target, and 54 to 56 Gy to the second clinical target.

“The medial group retropharyngeal nodes were never contoured as clinical target volume, aiming to spare the pharyngeal constrictors unless they were involved,” the researchers wrote. “[The] level 1b node was selectively contoured as clinical target volume in order to spare the submandibular glands and oral cavity.”

Patient-reported and observer-related scores assessed swallowing and salivary gland function at baseline and periodically up to 3 years after treatment.

Median follow-up was 39 months. At 3 years, researchers reported a local RFS rate of 93.6%, a regional RFS rate of 95.8% and a distant metastases-free survival rate of 80%.

Researchers reported no marginal or out-of-field relapses.

Patients’ dysphagia and xerostomia worsened during late courses of treatment, as well as after treatment, yet scores gradually improved after therapy. Dysphagia was minimal or absent at 9 months post radiotherapy, whereas xerostomia improved from 3 to 15 months post radiotherapy and remained steadily until the conclusion of follow-up.

“IMRT concurrent with weekly chemotherapy aiming to reduce xerostomia and dysphagia can be safely performed for locally advanced [nasopharyngeal carcinoma] and has high locoregional control rates,” researchers wrote. “Distant metastasis remains the main failure pattern. Long-term patient-reported and observer-rated swallowing and salivary glands function were only slightly worse than baseline.”

Note:
1. Wang XS. Abstract #P6.17. Presented at: WIN Symposium; July 10-12, 2013; Paris.

Lower radiation reduces xerostomia in head/neck cancer patients

Source: www.drbicuspid.com
Author: DrBicuspid Staff

Lowering the radiation dose to the submandibular gland of patients with head and neck cancer decreases xerostomia, according to a study presented on April 20 at the European Society for Radiotherapy and Oncology (ESTRO) meeting in Geneva.

Radiation oncologists at University Medical Center Utrecht (UMCU) showed for the first time that it is possible to reduce xerostomia in patients treated with radiotherapy for head and neck cancer if the radiation dose to a salivary gland (the submandibular gland) on the opposite side to the tumor is minimized, stated a university press release.

It is the largest study yet to show a correlation between radiation doses to the submandibular glands and their output of saliva. Guidelines for the recommended maximum dose could potentially be issued for use in clinical practice to benefit patients, according to the researchers.

Approximately 40% of head and neck cancer patients suffer from xerostomia in the long term, which causes problems with eating, sleeping, speech, tooth loss, and oral hygiene, leading to diminished quality of life, social isolation, and difficulty in the ability to work. Attempts to treat xerostomia and its consequences can be costly and are not very effective, the study noted.

Therefore, the UMCU researchers looked at using intensity-modulated radiotherapy (IMRT) to treat the tumors and spare the submandibular gland on the opposite side of the tumor and both parotid glands. They also wanted to determine the maximum radiation dose and how the treatment would affect patients’ xerostomia.

They analyzed 50 patients with throat cancers in which cancer cells had not migrated into the contralateral lymph nodes and had not metastasized to other parts of the body. The patients were treated with the contralateral submandibular IMRT and compared with a historical group of 52 patients who had received radiotherapy that had spared only the parotid glands.

After six weeks and after one year, the researchers measured saliva flow objectively from the submandibular and parotid glands by stimulating saliva with citric acid on the tongue and catching the resulting saliva in specially designed cups. They also used a questionnaire to measure the patients’ subjective experience of xerostomia.

Saliva flows from the contralateral submandibular glands were significantly higher at six weeks and at one year in patients who received a dose to the submandibular gland of less than 40 Gy, which translated into fewer complaints of xerostomia, the researchers reported. Using the new technique, they were able to keep the dose to less than 40 Gy in half of the patients.

All but one of the patients who could be treated with radiation doses of less than 40 Gy to the submandibular gland had small tumors (less than 4 cm in diameter). These patients consequently had fewer problems with xerostomia after a year.

The study could lead to guidelines recommending a maximum dose of 40 Gy for the submandibular gland, the researchers noted.

Understanding the connection between “dry mouth” and cavities

Source: www.hivehealthmedia.com
Author: Rob Gazzola

Do you have an unusually dry mouth? Do you suffer from bad breath, cracked lips, split skin at your mouth’s corners or a frequent sore throat? If your answer is “yes,” your symptoms may be caused by xerostomia, a condition caused by a lack of saliva. More commonly known simply as “dry mouth,” xerostomia can also cause difficulties swallowing and speaking and an altered sense of taste.

Even worse, the condition can lead to an increase of tooth decay and plaque. Saliva plays an important role in maintaining the health of your teeth and gums. It protects your teeth’s enamel by neutralizing potentially harmful acids, and it rinses food debris away from both the teeth and the gums. Without it, food particles, plaque and acid build up in your mouth, leading to tooth decay.

Luckily, there are many ways to improve dry mouth symptoms:

To stimulate the production of saliva, suck on hard candies or chew gum. Just make sure the varieties you choose are sugar-free.

Caffeine can dry out your mouth even more, so limit your intake of tea, coffee, soda and other caffeinated products.

Avoid foods and candies with high levels of acid or sugar. These foods can raise your risk of developing tooth decay.

When eating fruit, try to avoid dried fruit as generally they are high in sugar and often leave particles that cling to your teeth, while fresh fruit, though also having sugar content, is less likely to cause issues as the chewing stimulates the gums, increases saliva flow in the mouth and reduces the build-up of cavity-causing bacteria.

Protect your teeth by brushing with a fluoride toothpaste or using a fluoride rinse before bedtime, as saliva flow slows while you sleep, and it can be especially harmful to go to sleep without brushing your teeth.

Stay away from mouthwashes that contain alcohol. These products can dry out your mouth.

If you smoke or chew tobacco, quit.

Moisten your mouth by sucking on ice chips or sipping water throughout the day. Drinking water during meals can make it easier to swallow and chew.

While often not clearly understood, the causes and impact of dry mouth correlate directly with dental health and cavities, so look to protect your oral health by addressing cavity-causing activities and associated dry mouth symptoms.

Kentucky cancer center emphasizes patients’ quality of life

Source: www.drbicuspid.com
Author: Donna Domino, Features Editor

The James Graham Brown Cancer Center at the University of Louisville is among a growing number of facilities working to improve care for head and neck cancer (HNC) patients through collaborative care programs that bring together a spectrum of oncology specialists.

The center provides multidisciplinary treatment for HNC patients using novel techniques that decrease the debilitating side effects of radiation and chemotherapy. The clinic also conducts research and clinical trials with targeted therapies that aim to restore patients’ oral functions.

Kentucky has a higher rate of HNC than the U.S. average, which provides a large patient pool for the many clinical trials that the center conducts, according to Zafrulla Khan, DDS, MS, professor and director of maxillofacial/oncologic dentistry in the center’s HNC clinic.

“That’s what happens when you mix tobacco and bourbon,” Dr. Khan noted.

Intraoral radiation shields
Some of the center’s novel treatment techniques involve using intraoral radiation shields during brachytherapy radiotherapy procedures to prevent the tongue and nearby oral areas from getting irradiated while minimizing mucositis and xerostomia, Dr. Khan explained.

rad_shield1

Intraoral radiation shields prevent the tongue and nearby oral areas from getting irradiated while minimizing mucositis and xerostomia

“We put catheters right into tumors so they can deliver the radiotherapy in the mouth with high-density therapy machines rather than doing an external beam,” he said.

The clinic also uses a surgical obturator, a prosthetic device that enables patients to speak and swallow following surgery for maxillary sinus cancer. The maxillectomy procedure removes bones and tissue in the hard palate of the mouth, so when patients try to eat, the food can come through the nose, sinuses, and even into the lungs.

The device is similar to a denture or partial and includes a bulb that fills the opening in the roof of the mouth and part of the soft palate if it’s missing.

“It’s like a denture with a hump,” Dr. Khan explained. “It might be crude and simplistic but it gives patients the ability to eat orally and speak. That’s two major functions that are restored.”

The novel approaches are among the advantages of having a multidisciplinary team that includes maxillofacial oncologists, he noted.

rad_shield2

The surgical obturator is a prosthetic device that enables patients to speak and swallow following surgery for maxillary sinus cancer.

Previously, surgeons consulted with specialists individually, Dr. Khan said. Weekly meetings with the center’s specialists include an HNC pathologist, radiation oncologist, medical oncologist, otolaryngology surgeon, ear nose and throat specialist and Dr. Khan, who is a dental oncologist/maxillofacial prosthodontist.

Multidisciplinary approach
The center also has a palliative care physician for pain management, nurse study coordinator for the clinical trials, speech pathologist, and social worker for indigent patient needs such as transportation.

“We meet Friday mornings and everybody gets their two cents in,” Dr. Khan said. “What if we do this or that? So the overall plan is much better simply because everyone has input before you present treatment options to the patient. You’re not second guessing what the radiologist, medical oncologist or surgeon is thinking because they’re all at the table. I think it’s the only real way to treat cancer nowadays.”

One of his most interesting and unusual cases involved maxillary prosthodontics for a bodyguard whose face had to be largely replaced after he developed a fungal infection in his maxillary sinus. “He was a diabetic on steroids, and he ignored the infection too long,” Dr. Khan told DrBicuspid.com.

A specialty team including plastic, microvascular and maxillofacial oral surgeons performed a bilateral orbital exenteration (removing the contents of the eye socket), a maxillectomy (removal of the bones along the palatal fissure that forms the upper jaw) and also removed his upper lip.

“His face was pretty much carved off,” Dr. Khan said. “Everything was removed up to the base of his skull. We redid his face completely.”

The man’s eyes were replaced with prosthetic eyes and his upper palate was reconstructed with free flaps grafts from his fibula.

Afterward, his face was “reasonably acceptable,” Dr. Khan said. But sadly, he became sedentary after he lost his vision and died about seven years later when he was only in his 40s.

Improving quality of life
The first line of therapy for HNC patients is now shifting more toward radiation and chemotherapy, Dr. Khan observed.

“When I first started it was surgery followed by radiation because it was close to a positive margin and there might be nodal involvement,” he recalled. In fact, the center’s surgical rate for HNC dropped from 43% in 2004 to 23% in 2006.

“It makes a lot of sense because you can always do surgery later,” he noted.

All HNC patients must get a dental clearance and any needed extractions before radiation therapy to avoid complications later. “It’s essential and minimizes the side effects that you used to see,” Dr. Khan explained. “But there’s no escaping xerostomia and mucositis because that’s the nature of the therapy.”

HNC cases are hugely expensive, he noted. An average seven-day treatment course costs between $40,000 to $60,000 just for radiation therapy.

Some 40% of the patients are indigent, but their costs are covered because the center is a university-based hospital, he noted. “We never turn down patients because of their inability to pay.”

For Dr. Khan, the main priority is improving the lives of his patients.

“Quality of life is so critical,” he said. “I don’t care who the patient is, when they have a cancer diagnosis they’re devastated. Even if it’s a late diagnosis, we as dentists can make their quality of life a lot better.”

2013-02-20T07:32:57-07:00February, 2013|Oral Cancer News|

Perspectives on Coping Among Patients With Head and Neck Cancer Receiving Radiation

Source: MedScape News Today

Abstract and Introduction

Abstract

Purpose/Objectives: To describe coping among patients with laryngeal and oropharyngeal cancer during definitive radiation with or without chemotherapy.
Research Approach: Qualitative content analysis conducted within a larger study.
Setting: Two radiation oncology outpatient clinics in Baltimore, MD.
Participants: 21 patients with oropharyngeal or laryngeal cancer.
Methodologic Approach: Interviews with open-ended questions were conducted during treatment. Questions covered topics such as coping during treatment, treatment-related issues, and resources.
Main Research Variables: Coping, treatment, and coping resources.
Findings: Patients’ self-assessments suggested they were coping or that coping was rough or upsetting. Issues that required coping varied over four time points. Physical side effects were problematic during and one month after treatment completion. Patients used coping to manage the uncertainties of physical and psychological aspects of their experience. Family and friend support was a common coping strategy used by patients, with the intensity of side effects corresponding with the support provided across time points.
Conclusions: Findings confirm previous research, but also provide new information about ways in which patients with head and neck cancer cope with their illness experience. Emergent themes provide insight into patients’ feelings, issues, and assistance received with coping.
Interpretation: Patients with head and neck cancer need education on the amount and severity of side effects and should be appraised of potential difficulties with scheduling, driving, and other logistic issues. Patients also should be informed of helpful types of support and coping strategies. Additional research is needed to expand the findings related to patients’ coping with treatment and to explore the experiences of family and friends who provide social support.

Introduction

Head and neck cancer (HNC) accounts for 3% of all cancers in the United States and is twice as common in men compared to women (National Cancer Insitute [NCI], 2011). The incidence in the United States was estimated to be 52,000 new cases in 2011 (NCI, 2011). Treatment for HNC is multimodal, including surgery, radiation, and often chemotherapy. Patients’ illness experiences involve physical symptoms, side effects from treatment, symptom distress, and psychological distress (Archer, Hutchison, & Korszun, 2008; Haman, 2008). Patients also experience uncertainty about the effectiveness of an unfamiliar treatment, their ability to manage daily living, and long-term effects of the disease and treatment (Rose & Yates, 2001). Because of uncertainty, each patient perceives illness, cognitively appraises his or her situation, and copes with illness differently (Mishel, 1988).

Patients with HNC experience an array of physical symptoms resulting from their cancer and its treatment (Chandu, Smith, & Rogers, 2006). Symptoms related to side effects of radiation include dysphagia, xerostomia, pain, fatigue, altered taste, mucositis, skin changes, and weight loss (Olmi et al., 2003; Khoda et al., 2005). Symptoms related to side effects of chemotherapy include difficulty swallowing, anemia, nausea, neutropenia, diarrhea, and mucositis (Lambertz, Robenstein, Mueller-Funaiole, Cummings, & Knapp, 2010; Schrijvers, Van Herpen, & Kerger, 2004). Patients with HNC may experience several of those symptoms and side effects at any time during their treatment.

Symptom distress is defined as the degree or amount of physical or mental upset, anguish, or suffering experienced from specific symptoms (Rhodes & Watson, 1987). Few researchers have examined symptom distress among patients with HNC. Lai et al. (2003) reported that patients undergoing treatment had a moderate amount of symptom distress related to dry mouth, fatigue, loss of appetite, insomnia, and pain. Symptom distress also changes over time in response to the perceived difficulties of patients as a result of the physical and psychological demands of treatment (Haisfield-Wolfe et al., 2011). Symptom distress among patients with HNC can influence coping with symptoms and psychological distress (Elani & Allison, 2010).

Psychological distress, including the presence of anxiety, depression, and depressive symptoms, is present during the course of HNC treatment. Patients experience high levels of anxiety, particularly at diagnosis and pretreatment (Horney et al., 2011). Researchers have found depression and depressive symptoms prior to treatment (Baile, Gibertini, Scott, & Endicott, 1992; Davies, Davies, & Delpo, 1986), during treatment (Haisfield-Wolfe, McGuire, Soeken, Geiger-Brown, &, De Forge, 2009; Kugaya et al., 2000), at the completion of radiation treatment (Katz, Irish, Devins, & Gullane, 2003; Sehlen et al., 2003), and three months after diagnosis (Hammerlid, Silander, Hornestam, & Sullivan, 2001).

Uncertainty in illness is defined as an inability to determine the meaning of events, assign values to objects and events, and accurately predict outcomes (Mishel, 1988). Uncertainty and symptoms have been shown to interfere with adaptation to cancer (Bailey, Mishel, Belyea, Stewart, & Moher, 2004), and high levels of uncertainty interfere with coping (Mishel, 1984). In studies of patients with cancer, increased uncertainty has been related to depression (Bailey et al., 2004), poorer coping with stress (Badger, Braden, & Mishel, 2001), and inadequate psychological adjustment (Christman, 1990). However, few research studies have addressed coping in the context of uncertainty among patients with HNC.

Coping is defined as a “cognitive and behavioral effort to manage specific external or internal demands and conflicts that are appraised as taxing or exceeding the resources of a person” (Lazarus & Folkman, 1984, p. 112). Cognitive appraisal of taxing situations is a prerequisite for initiation of coping attempts that are aimed at adapting to the new reality of living with HNC. Variables associated with adaptation include those of a physical, psychological, and social nature. Research that investigates coping among patients with HNC, focusing on areas patients cope with and what coping strategies they use, is limited. Chaturvedi, Mbulaiteye, and Engels (2008) found that major concerns faced by patients with HNC were worries about their current illness and future (e.g., physical evaluation, communication, inability to perform usual tasks, finances, being upset).

During treatment, patients with HNC cope with symptoms and worries such as weight loss, dry and sore mouth, difficulty masticating and swallowing food, altered perception of taste, and missing meals (Lees, 1999). Patients receiving radiotherapy reported experiencing insufficient information and lack of time to ask questions (Larsson, Hedlin, & Athlin, 2007). Patients also have described coping with “disruption of their daily lives,” “waiting in suspense,” and “being left to their own devices” (Larsson et al., 2007, p. 324). Other areas identified as requiring coping after treatment were feelings of being self-diminished, underreported suffering, and loss of meaning in life (Moore, Chamberlain, & Khuri, 2004). Six to 12 months after treatment, patients were faced with physical changes, concerns about cancer, difficulties with work, interpersonal relationships, and social functioning (Semple, Dunwoody, Kernohan, McCaughan, & Sullivan, 2008).

Coping strategies used by patients with HNC vary. List et al. (2002) found that at pretreatment, patients with HNC primarily used social support. Recently treated patients with HNC used a greater number of coping strategies and commonly employed emotional ventilation, disengagement, denial, and suppression of competing activities (Sherman & Simonton, 2010). Elani and Allison (2010) found an association between levels of patients’ anxiety and depression and the types of coping strategies used. Those with higher levels used more self-blame, wishful thinking, and avoidance strategies. Thambyrajah, Herod, Altman, and Llewellyn (2010) examined benefit finding after HNC treatment and found that major themes were change in life priorities, greater closeness to family and friends, a greater awareness of self, and spirituality. Those few studies demonstrate that although patients with HNC are challenged with numerous physical, psychological, and social effects, their coping remains poorly understood.

Patients cope with symptoms and side effects, worry about disruption in their lives, and often are left to their own devices (Larsson et al., 2007; Lees, 1999). Patients also experience loss of meaning in life, underreport their pain, feel (or are) disfigured, and have changes in interpersonal relationships (Moore et al., 2004). They verbalize that they feel concerned about the uncertainties of cancer recurrence and daily living (Semple et al., 2008). Despite that large burden, few intervention studies have been designed to assist patients with HNC in coping. Learning more about how patients with HNC cope during each phase of their cancer experience will provide clarity in understanding the coping needs of and strategies used by this population.

The purpose of this study was to describe coping in the context of uncertainty among patients with laryngeal and oropharyngeal cancer during definitive radiotherapy with or without chemotherapy over four time points. This work was conducted as a substudy within a larger, longitudinal descriptive study (Haisfield-Wolfe et al., 2009) examining symptoms, symptom distress, depressive symptoms, and uncertainty.

Mishel’s (1988) Uncertainty in Illness Theory (UIT) guided the study research. UIT centers on an ill individual’s appraisal and coping with uncertainty. UIT views coping as a context-specific behavior in which an individual appraises and manages uncertain objects or events as a threat or as a positive challenge (Lazarus, 1967; Lazarus & Launier, 1978; Mishel, 1988). This substudy focuses on coping related to uncertainty. In designing this substudy, the researchers developed three open-ended interview questions to illicit information regarding how patients with HNC cope with treatment. Exploring coping within the context of uncertainty will help increase understanding of coping issues and strategies, with the ultimate aim of developing interventions that will improve practice.

Methods

Design, Setting, and Sample

The current study is a descriptive, qualitative content analysis of open-ended questions that patients answered about their coping during treatment. Patients were recruited from radiation oncology clinics at two cancer centers in Baltimore, MD. The sample consisted of 21 patients who met the following inclusion criteria: being aged 18 years or older, newly diagnosed with oropharyngeal or laryngeal cancer, and undergoing definitive radiation with or without chemotherapy. Patients were interviewed at four time points: week 1 (treatment initiation), week 5 (midpoint in treatment), week 9 (end of treatment), and week 12 (one-month visit with radiation oncologist after completion of radiation).

Procedures and Analysis

Approval was obtained from the human subjects institutional review boards at the University of Maryland Medical Center and Johns Hopkins Medical Institutions. Procedures were similar at each site, with physicians and nurses screening new patients for eligibility and identifying those interested in participating. Those individuals then were contacted by the researchers. Of 24 patients meeting inclusion criteria, 21 signed informed consent and provided demographic information. Patients who declined participation stated they were overwhelmed by their diagnosis and schedule. During a structured interview that was conducted as part of the larger study, researchers used the following prompts at each time point.

  • Tell me about how you are coping during treatment.
  • Tell me about any issues related to your treatment.
  • What resources are helping you to cope?

Depending on patients’ responses, the researchers occasionally asked additional questions for clarification. Patients were given as much time as needed to answer the questions, with the average interview lasting 15–30 minutes. Participants’ responses were recorded manually.

The recorded responses were categorized by time point and entered into a Microsoft® Word® document. Using a content analysis approach, the first author examined the text. A qualitative method was used to sort words and sentences having aspects related to each other by content and context into content areas (Graneheim & Lundman, 2004; Krippendorff, 2004). After rereading the whole interview again, content areas were labeled. The individual content areas were tabulated to identify the frequency with which they occurred (Krippendorff, 2004) and then discussed by the researcher and two HNC content area experts. When the researcher or the content experts had different perspectives, discussion occurred until consensus was reached. The categories and their content then were formulated into themes. Finally, the data were reviewed and judged by an HNC survivor who agreed that the themes and content reflected the experience of patients with HNC coping during and after treatment.

Study integrity was established using the aspects of trustworthiness: credibility, dependability, transferability, and confirmability (Lincoln & Guba, 1985). Credibility was demonstrated in the unique responses of patients with HNC to the interview questions, which focused on specific areas of coping with treatment. Dependability was demonstrated not only in the agreement among HNC experts and researchers regarding the results, but also by similar research findings in the literature that are reported in the Discussion section of this article. Transferability was judged by HNC content experts and an HNC survivor who reviewed the findings and agreed that they were transferable to other HNC contexts and settings. Finally, confirmability was maintained when a code book was developed and an audit trail of coding and content area decisions were recorded by the researchers to help ensure rigor and provide guidance for future research.

Results

Demographic and Clinical Characteristics

Sample characteristics are presented in Table 1 . Most patients were Caucasian, married, and men. The mean age was 59.2 years (SD = 9.2), and most patients had 12 years of education. Five patients reported a prior mental health disorder, and one patient was taking antidepressant medications. All patients were receiving radiation treatment at the time of the study, and 15 patients were receiving concomitant chemotherapy.

Open-ended Questions

Coping During Treatment: See Table 2 for the number of participants reporting each theme across time points. Exemplars for the three most prevalent themes that emerged related to coping are presented in Table 3 . At all four time points, the most prevalent theme was the patient’s self-perception of managing to cope. Responses revealed degrees of coping, for example, “quite well,” “as expected,” or “fair.” More than half of the patients reported they were coping with their illness and treatment. Although patients self-perceived they were coping across time points, they also identified physical and psychological issues that challenged their coping abilities. The second most prevalent theme was upsetting or rough experience, which increased over time. At the beginning of treatment, patients reported areas of difficulty with coping as stress related to disease and treatment. At midtreatment, patients reported bothersome side effects. At end of treatment, patients reported coping with aspects of treatment related to managing stressful events or severe side effects. One month after treatment, patients reported being upset about not feeling better by this point in time.

The third most prevalent theme was anticipation, which was highest at baseline and end of treatment (week 9). Patients were anticipating the end of both treatment and side effects. Responses that demonstrated anticipation included “I’m counting the days,” or “I can see the end of the tunnel.” Patients also reported using coping strategies (e.g., blogging, walking, accepting assistance from family or friends, acceptance of their illness, denial).

Issues Related to Treatment: Selected exemplars for the three most prevalent themes related to issues during treatment are presented in Table 4 . The most prevalent theme throughout the four time points was having physical side effects related to treatment, which increased at midtreatment and declined at end of treatment and one month after treatment. Patients reported 16 different side effects: weight loss, taste changes, sore throat, skin sores, pain, nausea, hiccoughs, hearing loss, fatigue, excess mucous, dry throat, difficulty talking, difficulty eating or swallowing, anorexia, and change in body image. One month after completion of treatment, patients still reported persistent symptoms (e.g, pain, difficulty swallowing, fatigue). Of note, the second most prevalent theme (six patients at weeks 5 and 9) was minimal or no issues, with the frequency declining over time. The third most prevalent theme was fear, anxiety, or worrying, which was present at all time points, but was most prevalent at baseline and one month after treatment. Exemplars emphasized the uncertainty associated with completion of treatment, for example, “fear of recurrence of cancer” and “don’t know what to expect.”

Assistance With Coping: Illustrative exemplars for the three most prevalent themes related to assistance are shown in Table 5 . The most prevalent theme was family support, with the majority of patients reporting family as the main source of support received over the four time points. The second most prevalent theme was friend support, which also persisted over four time points. Many patients told stories about how their friends and family had supported them. As the number of side effects increased at midtreatment and end of treatment, the number of individuals supporting the patient increased. At end of treatment (week 9), patients reported the importance of hospital personnel. One month after treatment, the amount of family support decreased and the interactions with friends increased. The third most prevalent theme was mental outlook, which increased over time. Coping strategies reported included Web support, keeping a normal schedule, weekly massage, walking, keeping busy, working at home, journaling, pets, and going to the mall for a few hours to take a “minivacation.”

Discussion

The results indicate that patients used coping to manage the uncertainties of physical and psychological aspects of their experience. Emergent themes provided insight into patients’ issues and feelings, as well as the support they received during treatment and afterward. Common themes uncovered for each question will be discussed briefly.

Coping at Each Treatment Time Point

Coping is defined as managing internal and external demands of illness (Lazarus & Folkman, 1984). Although the majority of patients perceived that they were coping, they reported different degrees of individual coping (e.g., “excellent,” “fair”) and noted issues that influenced how they coped, such as symptoms, fear, or anxiety. Therefore, most individuals appeared to be coping with the internal and external demands of treatment, with the exception of those who found their situation to be rough or upsetting. Interestingly, patients who reported that their coping was rough or upsetting were not the same grouping of patients across all time points. Patients reported better coping or more difficulty coping depending on the time point; for example, a patient who was coping adequately at baseline and midtreatment reported not coping well at end of treatment because of pain when swallowing. The adequacy of coping appeared to vary depending on the physical and psychological demands the patient had to face. Anticipation emerged at week 9 when patients were experiencing their worst symptoms and were anticipating the end of treatment and the results of their scans, which would determine whether the treatment was successful. That appears to be similar to the theme of waiting in suspense reported by Larsson et al. (2007), who studied patients with HNC six to eight weeks after radiotherapy. Those findings highlight a major issue among patients with HNC: the fear of recurrence experienced by cancer survivors. Coping interventions are needed to assist patients with that issue. One strategy is to educate patients about the wide variety of coping strategies used by participants in this substudy.

Issues Related to Treatment

Physical side effects of treatment were the most prevalent theme identified as an issue to be coped with, revealing specific areas of concern for patients with HNC and verifying findings of other researchers on coping with treatment side effects (Lees, 1999). Specific side effects included difficulty talking, eating, and swallowing; taste changes; excess mucous; and changes in body image. At the midpoint of treatment, patients reported coping with 17 different symptoms, with one patient reporting concurrent presence of three to four side effects at one time. The large number of symptoms patients coped with also has been reported by others (Hansen & Roach, 2007; Vissink, Jansma, Spijkervet, Burlage, & Coppes, 2003). Even one month after treatment, patients still identified pain (mainly in the throat), fatigue, and difficulty swallowing as issues. Treatment-related issues that were problematic for patients generally were related to the processes and procedures of radiation treatment, such as wearing a mask. Both treatment side effects and treatment-related issues revealed the complexities of the illness experience and the challenges posed to patients’ coping. Ten patients reported minimal or no issues at baseline, although that theme was less common at subsequent time points. That finding was surprising because patients were just starting their treatments and one might anticipate that they were coping with a variety of issues. Alternatively, patients simply may have been coping more effectively with their illness. In a study of patients with HNC, Moore et al. (2004) found that patients may underreport their pain and suffering. Finally, the theme of fear, anxiety, or worry was present at all time points, but particularly at baseline and end of treatment. Patients expressed distress about the uncertainties of their illness and their future. They were anxious about treatment and afraid of the outcomes. They worried about the cancer spreading, the treatment schedule, and whether they would endure their treatment. Those fears and worries have been observed by other researchers and clinicians (Hodges & Humphris, 2009). Clearly, uncertainties related to cancer cure and what the future holds are a major issue in the illness experience of patients with HNC. Additional study to determine interventions to assist patients in this area is needed.

Assistance With Coping

Patients used social support to cope with their treatment over the four study time points. They depended on their families and friends to assist them with many aspects of their lives, including traveling to outpatient clinic visits and radiation treatments, daily living activities, communicating with healthcare providers, managing symptoms, scheduling appointments, reading information and educational materials, and engaging in other activities to manage and cope with treatment. Patients also relied on those support people for companionship. As patients progressed with their treatment, more family and friend support was needed to cope with the resulting complexities. Patients used a broad range of coping strategies and also articulated acceptance of their situation or, occasionally, denial.

Of note, some patients took breaks from their situations by going to the mall or turning off their cellular phones to reduce disturbances to their focus on getting well. Sherman and Simonton (2010) reported coping strategies of ventilation, disengagement, and suppression of competing activities, but the wide array of activities reported in the current study provides insights into how patients may take the initiative to cope with their illness and treatment.

Mental outlook was a prevalent theme that helped patients’ cope, and that mindset increased as they progressed through treatment. Patients were convinced that they were getting through the treatment because of their mindset and that they were going to endure. That finding is important because it suggests that patients with a positive mental outlook represent a patient subgroup with a greater ability to cope. Each individual copes with illness and cognitively appraises his or her situation differently (Lazarus & Folkman, 1984). Therefore, mental outlook could have influenced the way patients coped with the physical and psychological demands of illness and treatment.

Limitations

The current study was limited by the unrecognized individual biases of the researchers and the HNC content experts who analyzed the data. Interviews were conducted at four time points during radiation treatment and, therefore, cannot reflect the entire experience of coping in patients with HNC. During interviews, patients were experiencing fatigue and other factors that may have affected the amount and degree of self-reporting that occurred. Finally, different ways to ask about coping may have revealed different perspectives.

Implications for Nursing

The findings confirm previous research, but also provide new information about the ways in which patients with HNC cope with their illness experience. In the clinical setting, patients with HNC should be educated regarding the number and severity of side effects they may experience and be appraised of potential difficulties with scheduling, driving, and other logistic issues. Patients also should be informed of the types of support and coping strategies that can be helpful. Healthcare providers also should inform patients that they may experience low energy during treatment, thus requiring support of significant others who can assist them with a variety of activities and issues.

Additional research is needed to expand the findings related to patients’ coping during and after treatment because this study was small with limited exploration of coping. For example, future researchers should explore the illness and coping experience of patients with HNC who perceive that they are coping adequately, but then report multiple treatment-related issues. Another area for future research is an exploration of the issues, burdens, and individual coping of family and friends who provide social support to patients with HNC during treatment, which can ultimately strengthen support for patients and reduce the negative impact of caregiving.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Cannabis chewing gum targets oral side effects

Source:
Author: staff

The company Medical Marijuana has acquired a 50% stake in CanChew, a cannabinoid (CBD)-based chewing gum developed as a pharmaceutical delivery mechanism to relieve pain, xerostomia, and other side effects of disease and disease treatment.

The acquisition gives Medical Marijuana worldwide exclusive rights to develop, manufacture, market, and distribute both tetrahydrocannabinol (THC) and non-THC hemp-derived cannabinoid-infused chewing gum to medical marijuana consumers, according to the company. The U.S. Food and Drug Administration currently considers non-THC based hemp products to be “food-based” and therefore legal without a medical marijuana license.

Cannabinoids have had positive effects in clinical trials on neuralgic pain, multiple sclerosis, and spinal cord injuries, nausea and vomiting from chemotherapy and radiation treatment, as well as palliative treatment of various cancers and HIV/AIDS, the company stated.

According to Sanammad, the company that developed CanChew, the gum can:

  • Alleviate acute and chronic pain
  • Diminish nausea and vomiting, as well as cachexia, which is a syndrome common in cancer patients on chemotherapy that causes appetite loss and loss of weight and muscle-mass
  • Enhance appetite
  • Improve muscle relaxation, coordination, and mobility
  • Diminish xerostomia
  • Promote fresh breath and maintain oral hygiene

“Functional chewing gum is well-established as an effective way to deliver pharmaceutical active ingredients,” said Michael Llamas, president of Medical Marijuana. “A great example is Nicorette. Within 10 minutes of chewing Nicorette gum, the consumer’s symptoms of nicotine withdrawal begin to ease. Our formulations also have an exceedingly safer side-effect profile compared to the currently available analgesics such as opioids, NSAIDs [nonsteroidal anti-inflammatory drugs], and Paracetamol (Tylenol).”

Dental oncology: Meeting a growing need

Source: Dr.Biscuspid.com

The good news is more cancer patients are surviving than ever before.

The bad news is it creates new challenges for the medical community to provide adequate and appropriate aftercare and treat the many short- and long-term side effects of cancer treatment.

For example, chemotherapy and radiation often cause oral problems such as mucositis, xerostomia, oral and systemic infections, and accelerated caries development. But many dentists refuse to treat cancer patients with these conditions due to the increased risk of osteonecrosis from radiation treatment or bisphosphonate use.

Enter Ryan Lee, DDS, MPH, MHA, who is finishing a postgraduate clinical fellowship in dental oncology at Memorial Sloan-Kettering Cancer Center in New York City. He hopes to help solve the shortage of dentists with the training to treat the growing number of cancer patients who need specialized oral care.

Ryan Lee, DDS, is one of a handful of dentists specializing in dental oncology.

Dr. Lee is one of two fellows in Sloan-Kettering’s dental oncology fellowship program, which has been offering the specialty training for at least a decade.

“All along I’ve liked working on medically complex cases with dental needs, so cancer fit into that niche very well,” he told DrBicuspid.com. “I’ve come to realize how much of a growing need it is and how little is available to meet that need,” he explained.

Currently, only two cancer hospitals offer fellowship training programs for dental oncology: the Memorial Sloan-Kettering Cancer Center and the University of Texas MD Anderson Cancer Center.

“Oncology training in the dental setting is a new and growing field, kind of a cottage industry,” Dr. Lee said. “When I went to dental school, cancer instruction was just a couple of lectures, and we learned mostly about oral cancer. We didn’t learn about the oral manifestations of systemic cancer that can be anywhere in the body.”

In fact, most of his patients don’t have oral cancers; most have breast or prostate cancer. And yet he sees hundreds of patients each month who present with cancer-related dental sequelae, including radiation-induced xerostomia, osteoradionecrosis, bisphosphonate-related osteonecrosis of the jaw, chemotherapy-related manifestations, oral (pre)cancerous lesions, and surgically resected jaws.

Dr. Lee also prescreens patients prior to bone marrow and stem cell transplants, head and neck radiation, and other cancer treatments.

“But we, as a dental profession, need to see these patients even when they’re outside the hospital setting,” he said. “The buzzword is oral systemic condition.”

An emotional toll

Some of Dr. Lee’s most difficult cases involve pediatric patients who have liquid tumors such as myeloma and often need chemotherapy and stem cell or bone marrow transplants.

“The effects of that are pretty severe in the mouth,” he said. “A lot of the children are missing teeth, and their adult teeth never fully develop so managing them throughout the course of their growth is a big issue — not only in clinical terms like chewing, eating, and smiling, but also the psychological impact.”

Treating cancer-stricken youngsters takes an emotional toll. “There’s nothing like seeing a bunch of kids with alopecia, and you know they’re going through cancer treatment,” Dr. Lee said. “It just breaks your heart.”

“Oncology training in the dental setting is a new and growing field, kind of a cottage industry.”
— Ryan Lee, DDS, Memorial
Sloan-Kettering Cancer Center

There are many physical challenges as well, he noted; for one, many patients must get a dental clearance before they start radiation therapy.

“When you get radiation to the jaw, it affects the blood vessels in such a way that you have nonhealing, so any dental extractions or oral surgery cannot be done after radiation to the mouth because of the risk of osteoradionecrosis,” Dr. Lee explained. “So we see a lot of those folks.”

Cancer patients also often need extensive oral surgery before they can be cleared for transplants.

“We often have patients that need 12 to 15 teeth extracted before they can go in for a transplant,” Dr. Lee said. Although the protocol calls for allowing three to four weeks for proper healing, sometimes they can’t wait due to the patient’s deteriorating condition and the urgent need for the transplant, he explained.

And during cancer treatment, a patient’s immunity is greatly diminished, which can result in abscesses and gingival inflammation, Dr. Lee said.

“You’ve got to manage these types of patients carefully, and these are the types of patients dentists on the outside really don’t want to deal with,” he noted.

Creative solutions

One of his most difficult cases involved a 29-year-old woman with fanconi anemia, an inherited blood disorder that leads to bone marrow failure. She subsequently developed squamous cell cancer in her mouth and has had multiple cycles of radiation, which puts her at a very high risk of osteoradionecrosis. She also has trismus (a contraction of the muscles of mastication), leaving her with limited ability to open her mouth because of the fibrosis, Dr. Lee explained.

“Because of her radiation history she has bursitis, and she’s full of mouth sores,” he said.

The woman is now missing a couple of front teeth and because of her fanconi anemia, she never developed adult teeth and now wants implants.

“Imagine performing oral surgery to place implants on someone who’s had that much radiation, who cannot open her mouth,” Dr. Lee said. “We can’t even take impressions because we can’t fit the tray into her mouth. That alone is an incredible challenge.”

He was forced to come up with creative solutions, including making customized smaller trays and using unusual materials.

“We’ve actually used butter just to be able to put a small impression tray in her mouth,” Dr. Lee said. “Having the tray in her mouth just hurts her so much because her gums are so inflamed.”

He is now focusing on dentures so she can stabilize the woman’s occlusion, but he must specifically measure how much radiation was given in the areas where the implants will be placed.

Fortunately, her illness is now in remission.

“She’s an incredibly smart person with such a great outlook, and she encourages me when I’m having a long day,” Dr. Lee said.

Influencing policymakers

Dr. Lee is encouraged by the work of Texas dentist Dennis Abbott, DDS, who specializes in oncology and has seen his practice grow quickly. Drs. Lee and Abbott met at a dental conference, and the two discussed the growing need for dentists who can treat cancer patients with specialized needs.

“It’s such a small, relatively unknown field,” Dr. Lee observed.

But Dr. Lee, who is working toward another doctorate in health policy, hopes to change that. In addition to becoming an academic-level dental oncologist, he would also like to practice part time treating the cancer-specific needs of patients.

“It would be nice to be able to influence policymakers and show them that dental oncology treatment is a medically necessary condition, that the effects on the mouth are severe,” Dr. Lee said.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Pig mucus effective at blocking viruses associated with cervical and oral cancer

Source: American Chemical Society

Scientists are reporting that the mucus lining the stomachs of pigs could be a long-sought, abundant source of “mucins” being considered for use as broad-spectrum anti-viral agents to supplement baby formula and for use in personal hygiene and other consumer products to protect against a range of viral infections. Their study appears in ACS’ journal Biomacromolecules.

In the report, Katharina Ribbeck and colleagues point out that mucus, which coats the inside of the nose, mouth and vagina, is the immune system’s first line of defense. The slimy secretion traps disease-causing microbes, ranging from influenza virus to HIV (which causes AIDS) before they can cause infection. That has led to consideration of mucin, the main component of mucus, for use as an anti-viral agent in a variety of products. However, existing sources of mucins, such as breast milk, cannot provide industrial-sized quantities. Large amounts of mucus exist in the lining of pigs’ stomachs, and the authors set out to determine if pig mucus – already used as a component of artificial saliva to treat patients with “dry mouth,” or xerostomia – has the same anti-viral activity.

They found that pig mucus is effective at blocking a range of viruses, from strains of influenza to the human papilloma virus, which is associated with cervical and oral cancer. They report that pig mucins could be added to toothpastes, mouthwashes, wound ointments and genital lubricants to protect against viral infections. “We envision porcine gastric mucins to be promising antiviral components for future biomedical applications,” the report says.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Oral Complications After Head/Neck Radiation ‘Underreported’

Source: Elsevier Global Medical News

Late oral effects of head and neck cancer therapy are “multiple, underreported, and under-appreciated. “That is the perspective of Joel Epstein, D.M.D., who has worked extensively with head and neck cancer patients experiencing severe dental and other oral problems following radiation therapy.

“The acute complications of head and neck cancer therapy are pretty well known, but the late complications are underappreciated,” Dr.  Epstein, director of oral medicine at City of Hope National Medical Center, Duarte, Calif., told attendees at the symposium. As head and neck cancer treatments have advanced and patients are living longer, the spectrum of treatment complications has shifted, he explained. In a 5-year, prospective longitudinal study of 122 patients with oral carcinoma, dry mouth, sticky saliva, speech changes, dental problems, and sleep disturbance were reported by all patients except those treated only with surgery. These complications persisted at 1 and 5 years and affected quality of life (Head Neck 2008;30:461-70).

According to Dr. Epstein, the data illustrate the need for better collaboration between oncologists and dentists. “While people discuss  the concept of multidisciplinary [and] interdisciplinary teams for the benefit of our patients, it is unfortunate that dentistry developed  separately from physicians and surgeons. So while we need to interact, we’re not really well prepared to do so, particularly in the  community,” he said.

Clinically, it’s important to evaluate oral care, including brushing, flossing, fluoride, and tobacco abstinence, at all head and neck cancer treatment follow-up visits. Patients should be assessed for xerostomia, speech, swallowing, mucosal sensitivity, and taste. Head and neck and oral exams should include assessments for saliva (wet mucosa), exposed bone, infection, and new lesions or recurrent cancer, and a dental exam (for plaque, caries, and periodontal health), Dr. Epstein recommended.

Dry mouth, in particular, can lead to a host of other chronic problems related to swallowing, eating, sleeping, and dental health. When the 50-item Vanderbilt Head and Neck Symptom Survey was administered to a total of 70 patients, 67 reported having dry mouth at more than 6 months’ follow up (Head Neck 2011 Aug. 24 [doi:10.1002/hed.21816]).

The majority reported that dry mouth makes chewing/swallowing difficult (65) and that it affects their ability to sleep (67) and  talk (64). With regard to eating and swallowing, similar majorities reported trouble eating solids (67) and drinking liquids (68), with food getting stuck in their mouth (66) and throat (67).

And, of concern, the same numbers of patients reported the sensation of choking or strangling on solids (66) and liquids (68). “The impact on function from the lack of saliva and the change in quality of saliva are issues we need to be more ready and willing to address,”  Dr. Epstein commented.

Taste and smell may also be profoundly altered. In the Vanderbilt survey, most patients reported altered taste (68), a decreased desire to eat (68), altered food choices (66), and a decrease in food eaten (66). A change in sense of smell was reported by 69 patients.

Such alterations often result in changes in diet, including decreased consumption of high-fiber food and of vitamins and other nutrients,  along with increased consumption of fats, caffeine, and sugar. All of these factors increase the risk for dietary deficiencies, as well as  dental caries.

Yet, altered taste sensation is not something patients might think to mention. “Half of patients experience altered taste sensation. But if  they think you’re not interested or you don’t ask, you may not know,”  Dr. Epstein commented.

Periodontal health is often compromised by hyposalivation, which can lead to inflammation, bone/attachment loss, oral infection, and necrosis. Dental demineralization and cavitation may develop as early as 2-3 months after cancer treatment and progress rapidly, leading to fractures of the gum line, tooth loss, and necrosis.

Demineralization appears as a change to white, which may not be recognized as a problem because of the belief that white teeth are  healthy. However, recognition at this stage is critical in order to prevent further dental damage, he said.

“The white change near the gum line and the tips of the teeth represent demineralization, and [in] time reversal can be accomplished  prior to structural breakdown. Once cavitation has occurred, fillings are needed and prevention must be instituted or the cavities will  recur and progress,” Dr. Epstein said in an interview.

In the Vanderbilt survey, reported dental problems included difficulty chewing because of teeth/dentures (54 of the 70 patients); tooth  sensitivity to hot, cold, or sweet foods (52); teeth feeling looser (51); teeth cracking/chipping (50); and trouble with dentures (24).

Oral candidiasis is another common problem, affecting approximately 39% of head and neck cancer patients during treatment and 33% afterward. One common clinical mistake is prescribing these patients antifungals that contain sugar, such as nystatin. “Nystatin is very high in sugar, and one of the [most commonly] used antifungals. The message is to avoid sugar-sweetened products in dry mouth patients and utilize alternatives,” Dr. Epstein said in the interview.

Mucosal sensitivity and pain is also frequent. In a meta-analysis of 22 studies published between 1990 and 2008, the prevalence of trismus was 25.4% in patients who received conventional radiotherapy and 5% for the few intensity-modulated radiation therapy studies that were included, suggesting that the newer radiation modality might diminish the problem (Support. Care Cancer 2010;18:1033-8).

Data suggest that the radiation effect on mandibular movement correlates with the radiation dose to the mastication muscles, with a  steep dose-response curve. Onset is typically 2-6 months post treatment and is ongoing. Concurrent chemotherapy may increase the  incidence and/or severity of mandibular immobility (Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endod. 1999;88:365-73).

In the Vanderbilt survey, most patients reported burning in the throat or mouth (69); sensitivity to hot, spicy, or acid food (67);  sensitivity to dryness (69); and changes in food intake because of mucosal sensitivity (67); most patients also reported that mucosal  sensitivity prevents tooth brushing (63). “Mucosal sensitivity is a quality of life issue,” Dr. Epstein said.

The Vanderbilt survey was particularly illuminating, Dr. Epstein commented. Studies that utilize claims data probably underrepresent  the problem of long-term oral complications because dental and medical insurance are separate and the data are not easily combined, he added.

“Late oral effects are best diagnosed [and] managed in a multidisciplinary team with close communication between medical and  dental providers. … We really need to come together.”

The Multinational Association of Supportive Care in Cancer is developing tools to improve communication between dentistry and  medicine. These could be available for beta testing as early as this fall.

Dr. Epstein said he had no relevant financial disclosures.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

 

Go to Top