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.
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.