xerostomia

Cannabis use and oral diseases

Source: Nature.com

Questions: What is the effect of cannabis usage on the oral environment?

Data sources
Medline and the Cochrane Central register of controlled trails (CENTRAL).

Study selection
Randomised Controlled Trials, Controlled Clinical Trials and Cohort Studies conducted on humans investigating cannabis usage were included. Screening was performed independently by two reviewers. Only English language studies were included. Case reports, letters and historical reviews were excluded.

Data extraction and synthesis
A narrative synthesis was conducted.

Results
Seven studies were included and a range of cannabis-associated oral side effects identified.

Conclusions
Based on the limited data, it seems justified to conclude that with increasing prevalence of cannabis use, oral health care providers should be aware of cannabis-associated oral side effects such as xerostomia, leukoedema and an increased prevalence and density of Candida albicans.

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

U of A study finds ways to help end dry mouth in cancer patients

Source: e! Science News

For patients suffering from cancer in the mouth or throat, a recent study shows that a treatment called submandibular gland transfer will assist in preventing a radiation-induced condition called xerostomia. Also known as dry mouth, xerostomia occurs when salivary glands stop working. University of Alberta researcher Jana Rieger likens the feeling of xerostomia to the experience of the after-effects of having surgery and anesthetic—but the feeling is permanent.

While the importance of healthy saliva glands may be an afterthought for some patients when battling cancer, the long-lasting effects create a number of problems for them when they are in remission.

“We need saliva to keep our mouths healthy,” said Rieger. “Without saliva, people can lose their teeth, dentures don’t fit properly and the ability to swallow and speak is severely altered.”

The study conducted by Rieger, a speech language pathologist in the Faculty of Rehabilitation Medicine, looked at functional outcomes—speech changes, swallowing habits and the quality of life of patients with mouth and throat cancers—as they received two different types of treatments prior to and during radiation.

The first group of patients underwent the submandibular gland transfer. This method was pioneered by Hadi Seikaly and Naresh Jha at the University of Alberta in 1999. The transfer involves moving the saliva gland from under the angle of the jaw to under to the chin. Prior to this procedure, the saliva gland was in line for the radiation. Seikaly says, “Most patients, when they are cured from cancer, complain of one major thing: dry mouth.”

The second group in the study took the oral drug salagen. Rieger says, “Studies have shown in the past that if this drug was taken during radiation, it might protect the cells in the salivary glands.”

According to the study findings, both groups had the same results in terms of being able to speak properly but where the main difference was in swallowing. The group taking the drug had more difficulty.

Rieger said, “This group needed to swallow more, and it took a longer time to get food completely out of their mouth and into the esophagus. Because they had trouble eating, they may become nutritionally comprised.”

This leads to a host of other problems. Dry mouth causes one to drink large volumes of water, which leads to numerous trips to the bathroom. Difficulty swallowing causes issues with eating food while it’s still hot and it takes the patients a long time to complete a meal.

As a result of these problems, Rieger found the quality life for most patients decreased significantly. “People suffering from xerostomia no longer want to go out eat and be in social settings. Consuming water to quench dry mouth means they have difficulty in getting a good night’s sleep. Some become depressed and avoid going out.”

Based on this study, the authors hope to encourage patients to have the submandiublar gland transfer as a preventative treatment for xerostomia prior to radiation for mouth and throat cancers.

 

Reirradiation with intensity-modulated radiotherapy in recurrent head and neck cancer.

Source: HighWire- Stanford University

In this retrospective investigation we analyzed outcome and toxicity after intensity-modulated reirradiation of recurrent head and neck cancer. METHODS: Thirty-eight patients with local recurrent head and neck cancer were evaluated. The median dose of initial radiotherapy was 61 Gy. Reirradiation was carried out with step-and-shoot intensity-modulated radiotherapy (median dose: 49 Gy). RESULTS: Median overall survival was 17 months, and the 1- and 2-year overall survival rates were 63% and 34%. The 1- and 2-year local control rates were 57% and 53%. Distant spread occurred in 34%, and reirradiation induced considerable late toxicity in 21% of the patients. Thirty-two percent showed increased xerostomia after reirradiation. The risk for xerostomia was significantly higher for cumulative mean doses of ?45 Gy to parotid glands. Considering median cumulative maximum doses of 53 Gy to the spinal cord and 63 Gy to the brainstem, no late toxicities were observed. CONCLUSIONS: Reirradiation with intensity-modulated radiotherapy in recurrent head and neck cancer is feasible with acceptable toxicity and yields encouraging rates of local control and overall survival.

� 2011 Wiley Periodicals, Inc. Head Neck, 2011.

February, 2011|Oral Cancer News|

Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial

Source: www.thelancet.com
Authors: Dr Christopher M Nutting FRCR et al.

Background:
Xerostomia is the most common late side-effect of radiotherapy to the head and neck. Compared with conventional radiotherapy, intensity-modulated radiotherapy (IMRT) can reduce irradiation of the parotid glands. We assessed the hypothesis that parotid-sparing IMRT reduces the incidence of severe xerostomia.

Methods:
We undertook a randomised controlled trial between Jan 21, 2003, and Dec 7, 2007, that compared conventional radiotherapy (control) with parotid-sparing IMRT. We randomly assigned patients with histologically confirmed pharyngeal squamous-cell carcinoma (T1—4, N0—3, M0) at six UK radiotherapy centres between the two radiotherapy techniques (1:1 ratio). A dose of 60 or 65 Gy was prescribed in 30 daily fractions given Monday to Friday. Treatment was not masked. Randomisation was by computer-generated permuted blocks and was stratified by centre and tumour site. Our primary endpoint was the proportion of patients with grade 2 or worse xerostomia at 12 months, as assessed by the Late Effects of Normal Tissue (LENT SOMA) scale. Analyses were done on an intention-to-treat basis, with all patients who had assessments included. Long-term follow-up of patients is ongoing. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN48243537.

Findings:
47 patients were assigned to each treatment arm. Median follow-up was 44·0 months (IQR 30·0—59·7). Six patients from each group died before 12 months and seven patients from the conventional radiotherapy and two from the IMRT group were not assessed at 12 months. At 12 months xerostomia side-effects were reported in 73 of 82 alive patients; grade 2 or worse xerostomia at 12 months was significantly lower in the IMRT group than in the conventional radiotherapy group (25 [74%; 95% CI 56—87] of 34 patients given conventional radiotherapy vs 15 [38%; 23—55] of 39 given IMRT, p=0·0027). The only recorded acute adverse event of grade 2 or worse that differed significantly between the treatment groups was fatigue, which was more prevalent in the IMRT group (18 [41%; 99% CI 23—61] of 44 patients given conventional radiotherapy vs 35 [74%; 55—89] of 47 given IMRT, p=0·0015). At 24 months, grade 2 or worse xerostomia was significantly less common with IMRT than with conventional radiotherapy (20 [83%; 95% CI 63—95] of 24 patients given conventional radiotherapy vs nine [29%; 14—48] of 31 given IMRT; p<0·0001). OCF. At 12 and 24 months, significant benefits were seen in recovery of saliva secretion with IMRT compared with conventional radiotherapy, as were clinically significant improvements in dry-mouth-specific and global quality of life scores. At 24 months, no significant differences were seen between randomised groups in non-xerostomia late toxicities, locoregional control, or overall survival.

Interpretation:
Sparing the parotid glands with IMRT significantly reduces the incidence of xerostomia and leads to recovery of saliva secretion and improvements in associated quality of life, and thus strongly supports a role for IMRT in squamous-cell carcinoma of the head and neck.

Funding:
Cancer Research UK (CRUK/03/005).

Authors:
Dr Christopher M Nutting FRCR, James P Morden MSc, Kevin J Harrington FRCR, Teresa Guerrero Urbano PhD, Shreerang A Bhide FRCR, Catharine Clark PhD, Elizabeth A Miles MPhil, Aisha B Miah FRCR, Kate Newbold FRCR, MaryAnne Tanay MSc, Fawzi Adab FRCR, Sarah J Jefferies FRCR , Christopher Scrase FRCR, Beng K Yap FRCR, Roger P A’Hern MSc, Mark A Sydenham BSc, Marie Emson BSc, Emma Hall PhD, on behalf of the PARSPORT trial management group.

Source:
The Lancet Oncology, Volume 12, Issue 2, Pages 127 – 136, February 2011

February, 2011|Oral Cancer News|

Reducing xerostomia through advanced technology

Source: The Lancet Oncology

Radiation-related xerostomia has been the most significant and disabling side-effect of radiotherapy for head and neck cancer for more than 50 years. With the PARSPORT trial, reported in The Lancet Oncology, the largest and best designed of several randomised trials focusing on xerostomia, radiation oncologists and their partners in physics and dosimetry should take pride that significant progress has been made. Before the introduction of intensity-modulated radiotherapy (IMRT), more than 80% of survivors experienced substantial dry mouth syndrome and associated effects on dental health, swallowing, taste, and quality of life. By contrast, Nutting and colleagues report about 25% of 2-year survivors had significant clinician-rated xerostomia. Taken together with two randomised trials of IMRT for nasopharyngeal cancer, there is now compelling evidence of the power of advanced technology in reducing toxicity from head and neck radiotherapy.

Can even better use of technology help us to further reduce xerostomia? The parotid glands provide watery saliva during eating, which is largely replaceable by consuming more water or lubricants. The submandibular, sublingual, and minor salivary glands provide mucinous saliva, associated with the resting sense of moisture and dry mouth symptoms. Future work should systematically explore the prioritisation of different components of the salivary gland system. A clinical benefit from sparing the submandibular glands may be seen, beyond that seen by sparing the parotid glands. The mean dose delivered to the minor salivary glands within the oral cavity has also been reported to be a significant factor in patient-reported xerostomia. Further possibilities include gland repair or regenerative strategies with stem cells, acupuncture, or acupuncture-like stimulation. The promise of intensity-modulated protons provides even more optimism for reducing xerostomia and other acute and late effects.

Another important aspect of PARSPORT is the evolution of quantitative methods to assess xerostomia—eg, pre and post stimulation salivary flow, quality of life, clinical grading, and diet tolerance scales. While there is no agreement on which is the gold standard, we should use multiple measures which reflect different aspects and perspectives (patient clinician) on the issue. One must recognise an inherent weakness in technology-based xerostomia trials: neither patients nor clinicians are blinded. However, for those practicing radiotherapy for head and neck cancer, and for our patients, the improved outcomes are empirically obvious every day. Xerostomia is now an uncommon first complaint among survivors more than 3 months from treatment. This concern has been replaced by the next most bothersome issues: swallowing, taste, and fatigue. Reduction in the burden of treatment-related side-effects is especially important given the increasing number of patients presenting with oropharyngeal cancer (85% of patients in PARSPORT had disease at this site), related to the surge in cases of HPV infection. Considering the excellent prognosis of patients with oropharyngeal cancer with no or minimal smoking history (>80% 3-year survival), the potential for striking reductions in duration and magnitude of symptom burden is clear. Several ongoing studies are examining strategies to reduce treatment intensity for these patients, including radiation dose reduction, and substitution of cytotoxic drugs with targeted agents (eg, the recently approved RTOG-1016 for HPV-positive cancers).

Lastly, a recent report suggests that surgical relocation of a submandibular gland might be an effective way to reduce the sense of dry mouth at rest. This intervention can be applied anywhere surgeons are trained for this procedure, in collaboration with two-dimensional radiotherapy, and demands further investigation. Some of us may under-appreciate that IMRT technology is available to less than 10% of the global population. Salivary gland transfer thus may have a more immediate and long-term effect on the global burden of radiation-related xerostomia than all the beam modulation done for many decades.

January, 2011|Oral Cancer News|

Less xerostomia occurs with IMRT in head and neck cancer

Source: www.medscape.com
Author: Roxanne Nelson

Intensity-modulated radiotherapy (IMRT) might be a better treatment option for patients with squamous cell carcinoma of the head and neck. Compared with conventional radiation therapy, IMRT significantly decreases the incidence of xerostomia and improves quality of life, according to a study published online January 13 in the Lancet Oncology.

British researchers report that at 12 months, grade 2 or higher xerostomia was significantly lower with IMRT than with conventional radiotherapy (38% vs 74%; P = .0027). At 2 years, the incidence of grade 2 or higher xerostomia continued to be significantly less common with IMRT than with standard radiotherapy; 9 patients (29%) reported xerostomia in the IMRT group, compared with 20 (83%) in the conventional therapy group.

The authors note that there were no significant differences in locoregional control or overall survival between the 2 patient groups.

Lead author Christopher M. Nutting, MD, FRCR, consultant and honorary senior lecturer in clinical oncology at the Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom, and colleagues note that their results “strongly support a role for IMRT in squamous cell carcinoma of the head and neck.”

Spares the Parotid Gland, Similar Outcomes
Head and neck oncology expert Ted Teknos, MD, agrees. “One of the advantages of IMRT is that you can deliver radiation very accurately and you can spare normal structures to a much higher degree than conventional radiation therapy,” said Dr. Teknos, director of the Division of Head and Neck Surgery at Ohio State University Medical School in Columbus.

“With IMRT, you can typically spare the opposite parotid gland, so that patients can have better salivary flow posttreatment,” said Dr. Teknos, who was approached by Medscape Medical News for independent comment. “Dry mouth is difficult to live with, and really affects quality of life.”

IMRT is commonly used. In fact, any facility that has the equipment will attempt to do parotid-sparing radiotherapy, he explained. It is the standard of care at his own institution, he said, adding that “it is the standard at many centers. The problem is that you need the technology to do IMRT. A lot of smaller medical centers may not have IMRT at their disposal. It is important for patients to ask the radiation oncologist if they have IMRT capability.”

Another important point is that IMRT is most effective in reducing xerostomia if the cancer is unilateral. “It is difficult to spare the parotid on both sides if there’s a midline lesion or the tumor originates in the nasopharynx,” Dr. Teknos explained.

The use of IMRT produces cancer outcomes similar to those observed with conventional radiation therapy. “That was seen in this paper and has been confirmed in many other studies,” he said. “There isn’t a trade-off in survival, but using IMRT can give a marked improvement in salivary flow and quality of life.”

Fewer Report Xerostomia
In this study, Dr. Nutting and coauthors evaluated the hypothesis that parotid-sparing IMRT will reduce the incidence of severe xerostomia. They randomized 94 patients with histologically confirmed pharyngeal squamous cell carcinoma (T1 to T4, N0 to N3, M0) from 6 British radiotherapy centers to treatment with either IMRT or conventional radiotherapy (47 in each treatment group).

In both study groups, the primary tumor and involved lymph nodes were treated with 65 Gy in 30 daily fractions, 5 days a week. Among postoperative patients, 60 Gy in 30 fractions was given unless there was macroscopic residual disease. Measurements of salivary flow were conducted prior to radiotherapy, at week 4 of treatment, and at 2 weeks and 3, 6, 12, 18, and 24 months after radiotherapy.

The median follow-up was 44 months (interquartile range, 30·0 to 59·7); 6 patients in each group died within 12 months.

At each time point from 3 to 24 months, the authors note that a smaller proportion of patients receiving IMRT than conventional radiotherapy reported grade 2 or higher subjective xerostomia. The proportion of patients reporting grade 2 or higher xerostomia at the 12 month time point did not differ by tumor site, radiotherapy indication, disease stage, or use of neoadjuvant chemotherapy.

At both 12 and 24 months, there were significant benefits in the recovery of saliva secretion with IMRT, compared with conventional radiotherapy. At 12 months, there was unstimulated saliva flow from the contralateral parotid gland in 47% of patients in the IMRT group, compared with none in the conventional radiotherapy group (P < .0001). Results were similar at 24 months (44% vs 0%; P < .0068).

There were also clinically significant improvements in dry-mouth-specific and global quality-of-life scores among patients who received IMRT.

At 24 months, there were no significant differences observed in nonxerostomia late toxicities. Fatigue was the only recorded acute adverse event of grade 2 or higher that differed between the 2 groups, and was more prevalent in the IMRT group (74% vs 41%; P = .0015).

Source: Lancet Oncol. Published online January 13, 2011.
Note: The study was funded by Cancer Research UK. The authors have disclosed no relevant financial relationships.

January, 2011|Oral Cancer News|

Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial

The Lancet Oncology, Early Online Publication, 13 January 2011

Dr Christopher M Nutting FRCR a b , James P Morden MSc b, Kevin J Harrington FRCR a b, Teresa Guerrero Urbano PhD c, Shreerang A Bhide FRCR a, Catharine Clark PhD d, Elizabeth A Miles MPhil e, Aisha B Miah FRCR a, Kate Newbold FRCR a, MaryAnne Tanay MSc a, Fawzi Adab FRCR f, Sarah J Jefferies FRCR g, Christopher Scrase FRCR h, Beng K Yap FRCR i, Roger P A’Hern MSc b, Mark A Sydenham BSc b, Marie Emson BSc b, Emma Hall PhD b, on behalf of the PARSPORT trial management group†

Summary


Background
Xerostomia is the most common late side-effect of radiotherapy to the head and neck. Compared with conventional radiotherapy, intensity-modulated radiotherapy (IMRT) can reduce irradiation of the parotid glands. We assessed the hypothesis that parotid-sparing IMRT reduces the incidence of severe xerostomia.

Methods
We undertook a randomised controlled trial between Jan 21, 2003, and Dec 7, 2007, that compared conventional radiotherapy (control) with parotid-sparing IMRT. We randomly assigned patients with histologically confirmed pharyngeal squamous-cell carcinoma (T1—4, N0—3, M0) at six UK radiotherapy centres between the two radiotherapy techniques (1:1 ratio). A dose of 60 or 65 Gy was prescribed in 30 daily fractions given Monday to Friday. Treatment was not masked. Randomization was by computer-generated permuted blocks and was stratified by centre and tumor site. Our primary endpoint was the proportion of patients with grade 2 or worse xerostomia at 12 months, as assessed by the Late Effects of Normal Tissue (LENT SOMA) scale. Analyses were done on an intention-to-treat basis, with all patients who had assessments included. Long-term follow-up of patients is ongoing. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN48243537.

Findings
47 patients were assigned to each treatment arm. Median follow-up was 44·0 months (IQR 30·0—59·7). Six patients from each group died before 12 months and seven patients from the conventional radiotherapy and two from the IMRT group were not assessed at 12 months. At 12 months xerostomia side-effects were reported in 73 of 82 alive patients; grade 2 or worse xerostomia at 12 months was significantly lower in the IMRT group than in the conventional radiotherapy group (25 [74%; 95% CI 56—87] of 34 patients given conventional radiotherapy vs. 15 [38%; 23—55] of 39 given IMRT, p=0·0027). The only recorded acute adverse event of grade 2 or worse that differed significantly between the treatment groups was fatigue, which was more prevalent in the IMRT group (18 [41%; 99% CI 23—61] of 44 patients given conventional radiotherapy vs. 35 [74%; 55—89] of 47 given IMRT, p=0·0015). At 24 months, grade 2 or worse xerostomia was significantly less common with IMRT than with conventional radiotherapy (20 [83%; 95% CI 63—95] of 24 patients given conventional radiotherapy vs. nine [29%; 14—48] of 31 given IMRT; p<0·0001). At 12 and 24 months, significant benefits were seen in recovery of saliva secretion with IMRT compared with conventional radiotherapy, as were clinically significant improvements in dry-mouth-specific and global quality of life scores. At 24 months, no significant differences were seen between randomised groups in non-xerostomia late toxicities, locoregional control, or overall survival.

Interpretation
Sparing the parotid glands with IMRT significantly reduces the incidence of xerostomia and leads to recovery of saliva secretion and improvements in associated quality of life, and thus strongly supports a role for IMRT in squamous-cell carcinoma of the head and neck.

Funding – Cancer Research UK (CRUK/03/005).

January, 2011|Oral Cancer News|

When East meets West, cancer patients win

Source: www.healthzone.ca
Author: Nicole Baute

An ancient four-herb formula used in China for 1,800 years might one day be available as a prescription pill to treat side effects caused by cancer chemotherapy, thanks to research from Yale University and a growing international consortium focused on the globalization of Chinese medicine.

Huang Qin Tang (pronounced Hu-ang Chin Tong) is made with peonies, a purple flower called skullcap, licorice and fruit from a buckthorn tree. The Chinese medicine has long been used for diarrhea, nausea, vomiting and cramps, which happen to be side effects associated with certain chemotherapy drugs.

Now research led by Yung-Chi “Tommy” Cheng, the Henry Bronson Professor of Pharmacology at Yale University, suggests a Western version of this ancient medicine may reduce gut damage caused by chemotherapy in colon and rectal cancer patients.

Cheng says a capsule preparation of this formula, called PHY906, inhibits three processes that cause inflammation during chemotherapy and enhances the recovery of damage to tissue.

“This is an example of West meeting East for treatment of cancer,” Cheng said, on the phone from Taiwan.

Cheng, who has equity interest in the Yale-sponsored company that licenses the technology, is focused on getting PHY906 licensed as a prescription drug in the U.S. — not as a supplement or alternative.

A study published in Science Traditional Medicine Wednesday explains how PHY906 restored intestinal damage in mice caused by chemotherapy and also helped trigger the replacement of damaged intestinal stem cells with healthy ones.

The drug is now in preliminary clinical trials in the U.S., and Cheng says early results have been encouraging.

The research is part of a growing effort to understand and Westernize Chinese medicine. Canadian researchers are amongst those on their way to Hong Kong for the 9th annual meeting of the Consortium for Globalization of Chinese Medicine, which begins on Monday. Cheng, who grew up in Taiwan, is chairman of the consortium’s board of directors.

Michael Rieder, the CIHR-GSK Chair in Pharmacology at University of Western Ontario and the university’s representative to the consortium, has been following — and occasionally critiquing — Cheng’s groundbreaking research.

“I’m a classical Western pharmacologist skeptical of a lot of stuff, so I said, ‘I want to see the proof in the pudding,’ ” Rieder said. “And this combination seems to be very effective. It’s been subject to rigorous testing, and it seems to be very useful as an adjunct to therapy for cancer.”

McMaster University will officially join the Consortium for Globalization of Chinese Medicine next week, becoming the second Canadian university involved.

Stephen Sagar, a professor of oncology at McMaster University specializing in radiation oncology, said technology made it possible for Cheng to split the herbs up into their chemical components, which helped him understand the chemicals that make Huang Qin Tang effective while ensuring consistency and quality.

For the past 15 years Sagar and his McMaster University colleague Raimond Wong have been researching Chinese medicine and its potential implications for cancer treatment. They are currently running a cross-North America trial on the effectiveness of acupuncture on treating xerostomia or dry mouth, a common side effect of chemo for head and neck cancers.

Rieder said the consortium’s aim is adjunctive therapy — Chinese medicine and Western science working together.

“The Western medicine is providing the cutting edge in terms of cure and killing disease, but the Chinese medicine is helping the patient tolerate it better and maybe helping the Western medicine work better,” he said.

September, 2010|Oral Cancer News|

Featured clinical trial: electroacupuncture for radiation-induced chronic dry mouth

Source: www.cancer.gov/ncicancerbulletin
Author: staff

Name of the Trial
Randomized Pilot Study of Electroacupuncture for Chronic Radiation-induced Xerostomia in Patients with Head and Neck Cancer (MAYO-MCS285). See the protocol summary 1.

Why This Trial Is Important
Head and neck cancers are often treated with external-beam radiation therapy 2. Although this treatment can be effective in controlling head and neck tumors, it may cause side effects 3 that can compromise a patient’s quality of life. Chronic dry mouth, also called xerostomia, is common among patients treated with radiation to the head and neck. This condition results from damage to the glands that produce saliva. Chronic dry mouth can have a major impact 4 on quality of life by causing pain and discomfort, affecting the ability to sleep, altering taste, and/or increasing the likelihood of dental problems.

Some drugs are available for xerostomia induced by radiation therapy, but many patients experience only a partial improvement or no benefit at all. The drug amifostine 5 can help protect the salivary glands of some head and neck cancer patients from radiation damage, but this drug cannot be used in all patients.

Some studies have suggested that acupuncture 6 can help relieve the sensation of mouth dryness in cancer patients who have undergone head and neck radiation therapy. Based on these studies and other evidence, researchers at the Mayo Clinic in Scottsdale, AZ, are investigating the ability of a procedure called electroacupuncture to help improve the production of saliva and the quality of life of patients with chronic dry mouth. Electroacupuncture involves stimulating traditional acupuncture points 7 on the skin using small electrodes instead of needles inserted into the skin.

In this clinical trial, head and neck cancer patients with chronic dry mouth who completed radiation therapy at least 6 months before joining the trial and who received no benefit from treatment with the drug pilocarpine 8 (Salagen) will be randomly assigned to undergo electroacupuncture using a machine called a LISS stimulator, or a sham procedure using a similar-looking machine that does not produce electrical stimulation. Treatment will last for 4 weeks (20-minute sessions 5 days a week for the first 2 weeks, and then 3 days a week for the last 2 weeks) and will be administered at the Mayo Clinic in Scottsdale. Saliva flow, the patients’ subjective sensation of mouth dryness, and quality of life will be assessed during the first 3 weeks of treatment and then again 1, 3, and 6 months following treatment.

“Depending on the radiation techniques used and the location of the tumor, up to 90 percent of head and neck cancer patients receiving radiation therapy will experience chronic dry mouth,” said Dr. Halyard. “Electroacupuncture is a non-needle approach that uses electrical stimulation of the acupuncture points thought to control salivation. The hypothesis is that this stimulation will alter the energy flow of the acupuncture points and result in an increase in saliva production.

“To date, we have enrolled 24 of 30 patients for the study, so we have 6 slots left,” Dr. Halyard continued. “I would be happy to discuss the study with any patients who think they might be interested and who can commit a month to treatment in Scottsdale, as well as return for the three post-treatment assessments.” (See contact information link.)

Notes:
1. Dr. Michele Haylard, Principal Investigator, Mayo Clinic Scottsdale
2. For more information:
See the lists of entry criteria  9 and trial contact information 10 or call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.

Table of Links:
1 http://www.cancer.gov/clinicaltrials/NCT00623129
2 http://www.cancer.gov/dictionary/?CdrID=46751
3 http://www.cancer.gov/dictionary/?CdrID=46580
4 http://www.ncbi.nlm.nih.gov/pubmed/17618467
5 http://www.cancer.gov/dictionary/?CdrID=45250
6 http://www.cancer.gov/dictionary/?CdrID=46724
7 http://www.cancer.gov/dictionary/?CdrID=449727
8 http://www.cancer.gov/dictionary/?CdrID=45573
9 http://www.cancer.gov/clinicaltrials/NCT00623129#EntryCriteria_CDR0000583031
10 http://www.cancer.gov/clinicaltrials/NCT00623129#ContactInfo_CDR0000583031

New report compares radiation approaches in head and neck cancer

Source: MedScape Today
Author: Nick Mulcahy

June 1, 2010 — Intensity-modulated radiation therapy (IMRT) for head and neck cancer leads to fewer cases of xerostomia, but has not yet been proven to be more successful than any other kind of radiation therapy in reducing tumors or improving survival, according to a new comparative-effectiveness review funded by the federal Agency for Healthcare Research and Quality (AHRQ).

The review compares the effectiveness of 4 types of radiotherapy (IMRT, 3DCRT, 2DRT, and proton-beam therapy) in terms of tumor control, overall survival, adverse events, and quality-of-life issues.

Many scientists consider IMRT to be theoretically better able to target cancerous cells while sparing healthy tissue than either 3DCRT or 2DRT, but more research is needed, the authors of the report point out.

The report, entitled Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, is authored by the Blue Cross and Blue Shield Association’s Technology Evaluation Center Evidence-Based Practice Center.

The late adverse effect of xerostomia, also known as dry mouth, is less common than in the past because the use of IMRT has allowed radiation oncologists to spare most patients’ salivary glands from radiation as part of treatment planning, an expert recently told Medscape Oncology.

Sparing salivary glands has become standard among clinicians who use IMRT, said Avraham Eisbruch, MD, professor of radiation oncology at the University of Michigan Medical School and Comprehensive Cancer Center in Ann Arbor.

Dr. Eisbruch’s comments came in the context of his study on the use of IMRT to reduce dysphagia in head and neck cancer. However, he also served on the technical expert panel of the new comparative-effectiveness report.

According to the report, it is not known whether IMRT is better or worse at reducing the size of tumors, or whether it improves other outcome measures.

“Inconsistent and nonsignificant results were observed between IMRT and comparators on other adverse events, overall quality of life, tumor control, and survival outcomes. Thus, the evidence is insufficient to support conclusions in these areas,” reads the report.

Overall, the report suffered from a lack of data with which to do comparisons, suggest the authors.

“A small body of randomized, controlled trials is accompanied by a larger body of poor quality observational, nonrandomized studies,” they write about the evidence on the topic.

What About Proton-Beam Therapy?

The main focus of the report was IMRT. An informal survey estimates that 30% to 60% of all patients in the United States are treated with IMRT.

The report authors note that “most of the studies in this review were based on the results of patients treated at academic medical centers.”

Because IMRT is increasingly adopted in community settings, the authors wonder whether results in head and neck cancer will continue to be the same.

“Whether similar results will be achieved as the technology diffuses to less-experienced settings has not been addressed in the comparative studies available for this review,” they write.

The authors sought to examine the evidence regarding proton beam radiation therapy, but there were no head-to-head comparisons to review.

“The strength of evidence is insufficient, as there were no studies comparing proton-beam therapy to any other radiotherapy modality. Therefore, no conclusions can be reached regarding the comparative effectiveness of proton-beam therapy,” write the authors.

Proton-beam radiation therapy is more commonly used to treat prostate cancer and pediatric tumors, the report notes.

In an AHRQ Technical Brief published last fall, researchers found limited evidence with which to determine whether proton-beam radiation therapy is safer or more effective than other types of radiation to treat cancer, according to AHRQ press materials.

The new comparative-effectiveness report is the latest research review from the AHRQ’s Effective Health Care Program, which is an effort to compare alternative treatments for health conditions and to make the findings public, to help doctors, nurses, pharmacists, and others work together with patients to choose the most effective treatments.

The authors are employees of Blue Cross and Blue Shield.

June, 2010|Oral Cancer News|