Rinse Eases Symptoms of Oral Mucositis in Cancer Patients

Veronica Hackethal, MD

August 27, 2014

A rinse for oral mucositis has been shown to offer significantly better symptom improvement than placebo in a randomized controlled trial. The mucoadhesive hydrogel (MuGard, Access Pharmaceuticals) coats the oral cavity and mucous membranes, and was approved by the US Food and Drug Administration (FDA) in 2006.

The manufacturer-sponsored study, published in the May 1 issue of Cancer, is the first randomized placebo-controlled trial of a medical product for oral mucositis, the researchers report.

Oral mucositis can be a debilitating adverse effect of cancer treatment, and can affect more than 40% of patients receiving radiation or chemotherapy, write Ron Allison, MD, radiation oncologist and medical director at 21st Century Oncology Carolina Radiation Medicine in Greenville, North Carolina, and colleagues. It can interfere with the intake of nutrition and fluids, and can lead to hospitalization and the placement of a feeding tube. Oral mucositis can also interrupt cancer treatment, reducing disease control and survival. In some cases, it can be life-threatening.

"Anything that can be implemented to minimize mucositis is a critical advance for both quality of life and treatment success. Something as simple as MuGard is a great advance," said Dr. Allison.

The study involved participants from 22 sites who were scheduled to receive chemoradiation therapy for head and neck cancer. The researchers assessed oral mucositis symptoms with patient self-reports and with evaluator assessments on the basis of World Health Organization (WHO) criteria.

For the efficacy analysis, 37 participants used the mucoadhesive hydrogel and 41 participants used a placebo saline bicarbonate rinse at least once daily for 2.5 weeks.

There was a significant decrease in patient-reported oral soreness with the hydrogel (P = .034) and in WHO oral mucositis scores assessed on the final day of radiation therapy (P = .038).

There was a nonsignificant trend toward delayed onset of mouth and throat soreness and less weight loss with the hydrogel. There was also a nonsignificant reduction in median duration opioid of use with the hydrogel, compared with placebo (6 vs 16 days).

No significant adverse events were reported.

Routine Use in All Chemoradiation Patients

"We routinely provide MuGard to all our patients receiving chemoradiation therapy," said Avraham Eisbruch, MD, associate chair for clinical research and professor of radiation oncology at the University of Michigan Health System in Ann Arbor, who was not involved in the study.

"While there are multiple products in the market, I was impressed by patients telling me that MuGard helps. It is quit striking, and now I make sure that patients use it," he told Medscape Medical News. "I don't prescribe 'magic mouthwash' any more."

The magic mouthwashes he was referring to are the generic mixtures of antibiotics, antifungals, antihistamines, corticosteroids, and antacids that are commonly used in such patients, although their efficacy has not been established. There are also a number of FDA-approved proprietary products for oral mucositis, including GelClair, Episil, Mucotrol, and Caphosol.

How well does MuGard work compared with these other treatments for oral mucositis?

There is no simple answer to that question, according to study researcher David Nowotnik, PhD, a consultant to and former senior vice-president of research at Access Pharmaceuticals, the manufacturer of MuGard.

"There is no well-established standard of care for mucositis because there have not been any controlled clinical studies comparing MuGard with other treatments," Dr. Nowotnik explained. However, the placebo saline bicarbonate rinse in this study is recommended by the National Cancer Institute as one treatment for mucositis, so the clinical trial did actually compare the hydrogel with one standard of care, he pointed out.

European studies have compared the hydrogel with a broad array of standard treatments, Dr. Nowotnik reported. Those studies have suggested that improvement in symptom onset, severity, and discomfort of oral mucositis is better with the product.

Access Pharmaceuticals has recently expanded its commercial efforts to provide treatments for supportive cancer care. In July, Access received FDA clearance for a similar product, called ProctiGard, for the treatment of rectal mucositis and radiation proctitis.

Dr. Allison reports receiving honoraria from Access Pharmaceuticals. Dr. Nowotnik was employed by Access Pharmaceuticals when this study was conducted. Several of the study coauthors report financial relationships with Access and other pharmaceutical companies. Dr. Eisbruch has disclosed no relevant financial relationships.

Cancer. 2014;120:1433-1440. Abstract

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