Spots Global Cancer Trial Database for Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.

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Trial Identification

Brief Title: Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.

Official Title: Use of PROMs in Conjunction With a Mucosa Topical Composition to Evaluate Oral Mucositis During Cancer Treatment and Post-treatment QoL in H&N Cancer Patients. An Interventional Two Phases Study, Part of the Stop Mucositis Project.

Study ID: NCT05635929

Conditions

Chemotherapeutic Toxicity

Interventions

Composition comprising olive oil, xylitol and betaine

Study Description

Brief Summary: PROMs questionnaires seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients. Despite this, few studies have been performed using patient reported outcomes in Head \& Neck (H\&N) cancer patients during and after treatment. The use of a novel topical mucosa composition (Saliactive®) is studied along the use of questionnaires.

Detailed Description: This study analyses the severity of oral mucositis of H\&N cancer patients along the first 6 weeks of radiotherapy with or without chemotherapy (Phase 1). Phase 2 evaluates Quality of Life in a pool of H\&N cancer patients 6 months after cancer treatment is completed. Quality of life of patients is analysed before (baseline) and after 1 month period of use of the tested composition (Saliactive®) begining 6 months after oncological treatment completion. During cancer treatment (Phase 1), mucositis may affect the course of therapy and long-term survival, while after treatment (Phase 2) chronic pain, xerostomia, dysphagia and speech limitations between others are behind anxiety and poor quality of life. The WHO oral mucositis scale together with a structured qualitative questionnaire to recover patient reported symptoms are used during phase 1. A validated Quality of Life questionnaire described by the University of Washington, is chosen for Phase 2 evaluation. Oral mucosa management is homogenized both during acute and chronic phase with the use of a composition (Saliactive®) which comprises olive oil, betaine and xylitol delivered in the form of a topical non-rinsing gel.