Study of Orosol Device for Treating Oral Mucositis Caused by Chemotherapy or Radiation in Cancer Patients Randomized, Double-Blind, Placebo-Controlled Trial

What this Trial Is About

Oral mucositis is a painful and common side effect of radiation therapy and chemotherapy, particularly in patients with head and neck cancers or hematological cancers. It results from damage to the rapidly renewing cells in the mouth, leading to ulcers that can worsen due to infections and toxin leakage. This condition can severely affect patients quality of life and may require changes in cancer treatment, which could impact disease outcomes. Current treatments mainly address symptoms, but options are limited in effectiveness. Researchers are evaluating Orosol, a medical device designed as a viscous, osmotically active solution that forms a protective film over mouth ulcers. By attracting fluid beneath the damaged tissue, Orosol helps cleanse ulcers of contaminants and toxins, reducing pain and promoting healing. In this randomized, double-blind study, 54 adult patients with chemo- or radiation-induced mucositis of grade 2 or higher will receive either Orosol or a placebo applied topically up to 34 times daily for a maximum of 28 days. Participants will be assessed at multiple visits on days 1, 3, 5, 7, 14, 21, and 28. Evaluations include clinical examination of mucositis severity using WHO and NCI-CTCAE scales, oral health status with the Oral Assessment Guide, pain and burning sensation measured by visual scales, photographs of ulcers, and monitoring of any changes in cancer treatments or adverse effects. The study aims to measure the improvement of mucositis symptoms and oral feeding ability after 28 days of treatment.

Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.