Use of Questionnaires and a Mucosa Topical Composition on Oncological Patients.

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 Phase Study, Part of the Stop Mucositis Project.

PROMs questionnaires seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients. Despite the disparity between physicians and patient's perception, few studies have been performed with PROMs in H&N cancer patients during and after treatment. The use of a novel topical oral mucosa natural composition (Saliactive®) is studied along the use of PROMs.

This study analyzes the severity of oral mucositis and oral mucositis related Quality of life of H&N cancer patients during the first 6 weeks of treatment (Phase 1). Phase 2 consisted in evaluating Quality of Life in a pool of H&N cancer patients 6 months after cancer treatment was completed. Patients were then tested before (baseline) and after a 4 week period using the tested composition. During cancer treatment (Phase 1), mucositis may affect the course of therapy and quality of life of patients, while after treatment (Phase 2) chronic pain, xerostomia, dysphagia and speech limitations between others are behind anxiety and poor quality of life. A validated PROMs questionnaire for oral mucositis described by Kushner et al, has been selected during the phase 1 where minimum value is 0 and maximum value is 100 whereas higher scores mean worst outcome. A validated Quality of Life questionnaire described by the University of Washington by Nazar et al, has been chosen for the Phase 2 evaluation where the best outcome is 1 and the worst is 4. Oral mucosa management will be homogenized both during the acute and the chronic phase with the use of a natural composition (Saliactive® which comprises olive oil, betaine and xylitol) delivered in the form of a topical non-rinsing gel and in the form of a water based rinsing solution.

oral mucositis, cancer therapy toxic effect, cancer support, pain, ulcers, treatment interruptions, sleep quality, oral mucosa

Comparison of symptoms reported by patient throughout the Patient-Reported Oral Mucositis Symptom scale and signs observed by the medical team. The chosen questionnaire consists on a Visual Analog Scale rated from 0 to 100 were higher scores mean a worse outcome.

Comparison of late symptoms reported by patient throughout the Spanish version of the University of Washington Quality of Life questionnaire at baseline and after 1 month using the tested composition. Each question offers several possible answers were higher scores mean a worse outcome.

Inclusion Criteria: Patients with diagnose of Head & Neck cancer that are going to receive cancer therapy (radio and/or chemotherapy). Exclusion Criteria: Patients taking drugs for xerostomia.

Kushner JA, Lawrence HP, Shoval I, Kiss TL, Devins GM, Lee L, Tenenbaum HC. Development and validation of a Patient-Reported Oral Mucositis Symptom (PROMS) scale. J Can Dent Assoc. 2008 Feb;74(1):59.

Nazar G, Garmendia ML, Royer M, McDowell JA, Weymuller EA Jr, Yueh B. Spanish validation of the University of Washington Quality of Life questionnaire for head and neck cancer patients. Otolaryngol Head Neck Surg. 2010 Dec;143(6):801-7, 807.e1-2. doi: 10.1016/j.otohns.2010.08.008.