Effect of a Novel Topical Composition on Severe Oral Mucositis and Quality of Life in Head & Neck Cancer Patients Undergoing Radiotherapy. A Two-Phase, Single-Arm, Interventional Clinical Trial.

What this Trial Is About

Researchers are studying the effect of a new topical mucosa composition called XCM-OM118, delivered as a gel and mouthwash, on severe oral mucositis in patients with Head & Neck cancer undergoing radiotherapy, with or without chemotherapy. The study also assesses patients' quality of life using patient-reported outcome measures (PROMs) to better understand their physical and emotional state during and after treatment. The study is divided into two phases. Phase 1 lasts six weeks during radiotherapy, where patients apply two pumps of the gel before bedtime, mid-morning, mid-afternoon, and before and after each therapy session. Phase 2 begins six months after cancer treatment completion and involves a one-month use of the gel and mouthwash to evaluate long-term quality of life. During this phase, patients complete questionnaires before and after the intervention. Participants will be monitored weekly during radiotherapy for oral mucositis severity using the WHO scale and patient questionnaires about pain and function. In Phase 2, quality of life is assessed using the University of Washington PROMs questionnaire covering pain, appearance, and activity. Researchers will track adverse effects such as allergic reactions or irritation throughout. The study aims to measure the frequency and timing of severe oral mucositis and changes in quality of life after using the composition.

Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.