HMB/Arg/Gln does not reduce oral mucositis incidence in head and neck cancer

Source: www.oncologynurseadvisor.com Author: James Nam, PharmD The addition of beta-hydroxy-beta-methylbutyrate, arginine, and glutamine (HMB/Arg/Gln) to opioid-based pain control (OBPC) and oral care programs does not effectively prevent chemoradiotherapy (CRT)-induced oral mucositis (OM) in patients with head and neck cancer (HNC), according to a study published in Supportive Care in Cancer. Chemoradiotherapy with a cisplatin-based chemotherapy regimen is the standard of care for patients with HNC, but is associated with a high incidence of CRT-induced OM. OBPC and oral care programs are insufficient in reducing OM incidence; there is a need for additional interventions to prevent and treat OM. For this phase 2 study, researchers treated 35 patients with HNC scheduled to receive definitive or postoperative cisplatin-based CRT with oral or percutaneous endoscopic gastrostomy-delivered HMB/Arg/Gln; all patients underwent OBPC and oral care programs. Results showed that 45.7% (16) of patients developed symptomatic or functional grade 3 or worse OM. Grade 1 or less OM occurred in 51.1% of patients at 2 weeks and in 82.9% of patients at 4 weeks postradiotherapy completion. Clinical examination, however, revealed that 28.6% (10) of patients developed grade 3 or worse OM, and the incidence of grade 1 or less OM was 80.0% and 100% at 2 weeks and 4 weeks after completing radiotherapy, respectively. The most frequently reported adverse events included diarrhea and an increase in blood urea nitrogen, but were easily managed with standard care. Evidence from the study demonstrates that HMB/Arg/Gln does not effectively decrease OM incidence; however, the authors concluded that “the [...]

New “soft” laser treatment to improve quality of life for cancer patients

Source: www.world-first.co.uk Author: staff A new "soft" laser therapy is to be used nationwide to help prevent patients undergoing treatment for neck and head cancer from suffering severe side effects. The low-level laser therapy (LLLT), or photomedicine, will help prevent patients suffering from soreness in the mouth and throat, dry mouth and swallowing problems. More than 90% of the 4,000 people a year in England and Wales who receive chemoradiotherapy for head and neck cancer experience side effects which can lead to hospital admissions and, in some cases, interrupt the course of radiotherapy. The new treatment, developed by the NHS foundation trusts of University Hospital Southampton and Newcastle Upon Tyne Hospitals, is being trialled nationwide as part of a £1.2 million study funded by the National Institute for Health Research (NIHR). One of the main complications of current treatments is oral mucositis (OM), which affects taste and speech. It causes excessive secretions of saliva, which result in nausea, vomiting and weight loss. Currently, patients are treated with a combination of painkillers and anti-sickness drugs and many require frequent hospital appointments to control their symptoms. Some also need nutritional support through nasal or stomach feeding tubes. LLLT is a drug-free treatment that stimulates damaged cells using a low energy laser beam to reduce pain and inflammation. It's more commonly used to treat musculoskeletal problems such as tendon, bone and nerve damage. Consultant clinical oncologist at Southampton General Hospital Dr Shanmugasundaram Ramkumar said the LLLT would improve quality of life for patients. [...]

Laser Treatment Halts Oral Mucositis in Its Tracks

Source: www.medscape.com Author: Fran Lowry   Spa-like treatment with a cool, low-level laser, similar to that use for wrinkles, vanquishes oral mucositis, one of the most debilitating toxicities of cancer therapy.   "I have been an oncology nurse for over 25 years, and in those 25 years, there has been nothing that helps prevent or is effective against the treatment for oral mucositis, until now," said Annette Quinn, RN, MSN, from the University of Pittsburgh Cancer Institute.   "Patients say they rank it higher than nausea and vomiting when it comes to adverse side effects, especially because we have good medications to control nausea and vomiting. But the low-level laser works better than we could have hoped," Quinn told Medscape Medical News.   She presented results from a pilot project at the Oncology Nursing Society (ONS) 40th Annual Congress in Orlando, Florida.   Oral mucositis affects virtually all head and neck cancer patients undergoing chemo and radiation therapy, and about 75% to 100% of patients undergoing stem cell transplantation with whole-body irradiation experience some degree of oral mucositis.   Low-level laser therapy (LLLT) has been used to treat oral mucositis for a decade in Europe and South America, but it has not made its way to the United States because there is no mechanism for reimbursement, Quinn reported.   She hopes this study will change that.   "Reimbursement is the main obstacle to its use in the United States, but for this study, I was able to secure the treatment [...]

2015-05-04T10:29:44-07:00May, 2015|Oral Cancer News|

Consider dental issues before beginning cancer treatment

Soure: www.curetoday.com/ Author: Lacey Meyer Dentists advise resolving tooth and gum issues before starting cancer treatment. Bettye Davis admits she has never had very good teeth. But when she received a diagnosis of salivary gland cancer, she was surprised that her oncologist recommended she visit a dentist before beginning radiation treatments to her jaw. “When we first saw her, she still had quite a few teeth, but she had severe periodontal disease and severe bone loss,” says Dennis Abbott, DDS, Davis’ dentist. Knowing radiation would do more damage, he recommended removing the remainder of her teeth and allowing time to heal before she began 33 radiation treatments. “We knew that if we took the teeth out after radiation, we risked the bone not healing well, which would have meant osteonecrosis, dead bone in her mouth, and lots of systemic problems.” According to the National Cancer Institute, eliminating pre-existing dental and mucosal infections and instituting a comprehensive oral hygiene protocol before and throughout therapy can reduce the severity and frequency of oral complications from cancer therapy. Abbott says the NCI recommendations, as well as an increasing number of studies, are bringing more recognition to the importance of dental issues before, during and after cancer treatment. A Proactive Approach Abbott’s goal is to help patients maintain healthy teeth and reduce the risk of future infection with an oral care plan that eliminates or stabilizes disease that could produce complications during or following therapy. These complications can range from irradiated bone and gums [...]

2011-12-22T15:08:57-07:00December, 2011|Oral Cancer News|

NephRx Licenses Patent for Oral Mucositis Treatment

Source: Dr.Bicuspid.com November 30, 2011 -- NephRx has gained rights to a U.S. patent related to the company's novel peptide NX002, which is being developed for the treatment of oral mucositis and diseases of the gastrointestinal tract. Rights to U.S. patent No. 8,017,576, "Methods and compositions to treat mucositis" -- which protects NX002 and related compounds -- have been exclusively licensed to NephRx by the University of Chicago, where the drug was discovered in the laboratory of Dr. F. Gary Toback. Previously, NephRx reported that NX002 had demonstrated significant efficacy when tested in well-validated animal models of oral mucositis. Animals treated with NX002 had reduced levels of oral ulceration and a more rapid recovery, with no evidence of toxicity. The company is preparing to conduct detailed toxicity studies necessary to move forward with the NX002 clinical program, according to NephRx President and CEO James Koziarz NX002 is a peptide derived from the naturally occurring growth factor AMP-18, which has been shown to stimulate the growth of epithelial cells and promote mucosal wound healing after injury. This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

2011-12-01T12:31:52-07:00December, 2011|Oral Cancer News|

EU grants orphan drug status to BioAlliance Pharma’s clonidine Lauriad

Source: www.pharmabiz.com Author: staff European Commission has granted orphan drug designation to BioAlliance Pharma SA's clonidine Lauriad for prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer. Oral mucositis is a very frequent inflammation of the oral mucosa in head and neck cancer patients treated with radio- and chemotherapy (98,000 new patients estimated per year in Europe). Severe oral mucositis occurs in 60% of these patients and may induce intense oral pain and eating disability requiring artificial nutritional support. In 20 to 30% of cases, patients have to be hospitalized and the disease may result in a modification or a stop of the radiotherapy treatment in more than 10% of them. Radiotherapy-induced oral mucositis has currently no preventive cure. In Europe, the orphan designation is granted for medicinal products in diseases affecting less than 5/10,000 patients. This status permits to benefit from incentives related to the clinical development, thus enabling a faster registration, and an extra protection with a 10- year commercial exclusivity after market authorization. “The European designation for clonidine Lauriad as an orphan drug is key in shortening its development timeline, optimizing costs and reinforcing its future market access. Clonidine Lauriad, currently in Phase II clinical trial, is the second product from our “Orphan Oncology Products” portfolio to be granted orphan status in Europe. The portfolio comprises assets with high commercial potential and will leverage our future growth”, stated COO, Judith Greciet. Dedicated to cancer and supportive care treatment with a focus on resistance targeting [...]

2011-11-06T10:14:20-07:00November, 2011|Oral Cancer News|

Palifermin Decreases Severe Oral Mucositis of Patients Undergoing Postoperative Radiochemotherapy for Head and Neck Cancer: A Randomized, Placebo-Controlled Trial

Source: OncologyStat.com TAKE-HOME MESSAGE This randomized, placebo-controlled trial found that weekly palifermin was associated with decreased incidence and duration of severe oral mucositis in patients undergoing postoperative chemoradiotherapy for head and neck cancer. SUMMARY OncologySTAT Editorial Team Combined chemoradiotherapy (CRT) offers improved outcomes after resection of locally advanced head and neck cancer but also increases the risk of oral mucositis, a debilitating and potentially dose-limiting toxicity of locoregional treatment. Palifermin, an analogue of keratinocyte growth factor, is FDA approved to prevent and treat mucositis in patients undergoing high-dose myelotoxic therapy for hematologic malignancies. In this multicenter, randomized, placebo-controlled trial, Henke et al evaluated whether palifermin reduces severe oral mucositis in patients undergoing CRT after surgical resection of locally advanced head and neck cancer. Adult patients receiving postoperative CRT for high-risk stage II to IVB head and neck squamous cell carcinoma and with an ECOG performance status of 0 to 2 were enrolled from 38 centers in Europe, Australia, and Canada. Eligible study patients were stratified by tumor location (oral cavity/oropharynx or hypopharynx/larynx) and residual tumor (R0 [complete resection] or R1 [incomplete resection]). Study patients received a radiation dose of 60 Gy (R0 group) or 66 Gy (R1 group) plus cisplatin 100 mg/m2 on days 1 and 22, with the study drug administered 3 days prior to starting CRT and then weekly for 6 weeks. Patients who underwent radiotherapy after 6 weeks received an additional 100 mg/m2 of cisplatin and study drug. Oral saline rinses, topical anesthetics, feeding tubes, and hematopoietic [...]

2011-09-20T10:21:43-07:00September, 2011|Oral Cancer News|

Palifermin Decreases Severe Oral Mucositis of Patients Undergoing Postoperative Radiochemotherapy for Head and Neck Cancer: A Randomized, Placebo-Controlled Trial

Source: Journal of Clinical Oncology Purpose: Radiochemotherapy of head and neck cancer causes severe mucositis in most patients. We investigated whether palifermin reduces this debilitating sequela. Methods: We conducted a multicenter, double-blind, randomized, placebo-controlled trial in 186 patients with stages II to IVB carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patients received 60 or 66 Gy after complete (R0) or incomplete resection (R1), respectively, at 2 Gy/fraction and five fractions per week. Cisplatin 100 mg/m2 was administered on days 1 and 22 (and on day 43 with R1). Patients were randomly assigned to receive weekly palifermin 120 μg/kg or placebo from 3 days before and continuing throughout radiochemotherapy. Trained evaluators performed oral assessments twice weekly. The primary end point was the incidence of severe oral mucositis (WHO grades 3 to 4). Overall survival and time to locoregional progression were also assessed. Analysis was by intention to treat. Results: Severe oral mucositis was seen in 47 (51%) of 92 patients administered palifermin and 63 (67%) of 94 administered placebo (P = .027). Palifermin decreased the duration (median, 4.5 v 22.0 days) and prolonged the time to develop (median, 45 v 32 days) severe mucositis. Neither patient-reported mouth and throat soreness scores nor treatment breaks differed between treatment arms. After median follow-up of 32.8 months, 23 deaths (25%) had occurred in both treatment arms, and disease had recurred in 25 (27%) and 22 (24%) of palifermin- and placebo-treated patients, respectively. Conclusion: Palifermin reduced the occurrence of severe oral mucositis in [...]

SciClone Pharmaceuticals Inc enrols first patient in Phase 2b trial of SCV-O7 for oral mucositis

Source: www.therapeuticsdaily.com Author: staff Specialist pharmaceutical company SciClone Pharmaceuticals Inc (NASDAQ:SCLN) revealed on Tuesday that the company has enrolled the first patient in its phase 2b clinical trial of SCV-07 for the prevention of oral mucositis (OM), a painful, debilitating and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. The company said that the study will examine three doses of SCV-07, including two higher doses than those used in the recent phase 2a study, to assess the drug's impact on modifying the course of OM in patients with head and neck cancer. This multi-centre, randomised, double-blind, placebo-controlled study will enroll approximately 160 subjects who are receiving standard chemoradiation therapy for treatment of cancers of the head and neck. Subjects will be randomly assigned to one of the trial's four treatment arms: placebo and SCV-07 at doses of 0.1 mg/kg, 0.3 mg/kg and 1 mg/kg. According to the company, SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which appears to stimulate the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells.

SciClone identifies unique genetic markers associated with patient response to SCV-07 treatment in oral mucositis

Source: www.marketwatch.com Author: press release SciClone Pharmaceuticals, Inc. today announced that researchers have identified two unique gene clusters that differentiated subjects who responded to treatment in the Company's phase 2a proof of concept study of SCV-07 for the prevention of severe oral mucositis (OM; WHO grades 3-4) in patients with advanced head and neck cancer. The Company believes that the discovery of these gene clusters may assist in providing the framework for effectively identifying those patients most likely to respond to SCV-07 in future clinical trials based on their individual genomic profile or gene signature. These findings were presented today in a poster presentation at the 4th American Association for Cancer Research (AACR) International Conference on Molecular Diagnostics in Cancer Therapeutic Development. As part of the Company's recently completed phase 2a OM study, researchers collected and analyzed RNA samples from patients prior to and at the completion of the trial's treatment phase. Results from this gene expression analysis demonstrated the strong association of two specific gene clusters with patient response to SCV-07. Consistent with SCV-07's activity as a modulator of the immune system, these clusters included genes associated with G-protein coupled receptors, signal transducers, glycoproteins and membrane proteins. "The identification of these specific genetic markers represents an exciting and potentially powerful development in the clinical advancement of SCV-07 for the treatment of oral mucositis," said Dr. Stephen T. Sonis, speaking in his role as Chief Medical Officer of Biomodels, LLC. Dr. Sonis is also a Clinical Professor of Oral Medicine [...]

2010-09-30T12:56:10-07:00September, 2010|Oral Cancer News|
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