(ChemotherapyAdvisor) – Patients undergoing chemoradiation therapy for head and neck cancer experienced a significant reduction in mouth and throat soreness and a significant delay to onset of oral mucositis after using a novel mucoadhesive oral protectant (MuGard™), results of a phase 4 clinical trial presented during the International Symposium on Supportive Care in Cancer, New York, NY, June 28-30, has found.

The mouth rinse also produced significant reductions in weight loss during therapy and in the use of opioid pain medication, according to Ron R. Allison, MD, of Carolina Radiation Medicine, Greenville, NC, one of the trial’s principal investigators.

Data on 70 of a planned 120 enrollment were presented from the ongoing prospective, randomized, multicenter, double-blind, placebo-controlled clinical trial, in which patients with head and neck cancer whose treatment plan calls for receiving up to a maximum cumulative radiation dose of 72 Gy are randomly assigned to receive the mouth rinse or a control rinse. The efficacy analysis population comprises patients who stayed on study treatment through chemoradiation (approximately 7 weeks); the full analysis data set represents all subjects enrolled and randomized with at least 1 postradiotherapy assessment.

Continue Reading

Baseline demographics were well balanced for age, gender, ethnicity, and mean Karnofsky score. The pain end point is a measure of reduction in mouth and throat soreness over the course of cancer therapy as measured with the Oral Mucositis Daily Questionnaire. The delay to onset of oral mucositis end point measures cumulative dose of radiation; the time to first occurrence end point measures, in days, time of first occurrence of oral mucositis.

Compared with the control rinse, patients in the mucoadhesive oral protectant arm had a significant reduction in mouth and soreness pain; P=0.041 for the efficacy analysis population, with a strong trend in the full analysis population (P=0.110), which resulted in decreased use of opioids. Patients in both populations experienced a significant delay to onset of oral mucositis (P=0.020 and P=0.007, respectively) as well a delay in time to first occurrence (P=0.022 and P=0.009, respectively).

The study also measured weight changes at various periods. Patients in the efficacy analysis population experienced a significant reduction in weight loss (P=0.036) between start and completion of radiation treatment, Dr. Allison noted. Mean weight loss was 9.1 kg for the control arm and 5.2 kg for the mucoadhesive oral protectant arm. This suggests that patients using the mouth rinse were able to keep themselves better nourished during chemoradiation by better tolerating treatment.

The International Symposium on Supportive Care in Cancer is sponsored by the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology.


Clinicaltrials.gov Listing

Press release