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

Study Overview
=================
Brief Summary
-----------------
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 questionnaires.

Detailed Description
-----------------
This study analyses the severity of oral mucositis of H&N cancer patients during the first 6 weeks of treatment (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 a 1 month period using the tested composition (Saliactive®) starting 6 months after oncological treatment ends. 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. The WHO oral mucositis scale together with a structured qualitative questionnaire to recover patient reported symptoms are used during the phase 1. A validated Quality of Life questionnaire described by the University of Washington, is chosen for the Phase 2 evaluation. Oral mucosa management is 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.

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.

Conditions
-----------------
Oral Mucositis, Quality of Life, Mucositis, Pain, Speech, Saliva

Intervention / Treatment
-----------------
* Combination Product: Composition comprising olive oil, xylitol and betaine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single group, interventional, open-label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute group (Phase 1)<br>Patients during oncological treatment | Combination Product: Composition comprising olive oil, xylitol and betaine<br>* Topical composition in the form of a gel.<br>|
| Experimental: Chronic group (Phase 2)<br>Patients 6 months after oncological treatment is finished | Combination Product: Composition comprising olive oil, xylitol and betaine<br>* Topical composition in the form of a gel.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of severe oral mucositis. | Frequency of severe oral mucositis, grades 3 and 4, as measured by the WHO scale to be assessed during the 6 weeks of oncological treatment. The WHO scale was used to clinically assess oral mucositis grade based on physician observation of mucosa tissue damage from grade 0 (no tissue injury), grade 1 (presence of erythema), grade 2 (presence of ulcers with or without erythema), grade 3 (confluent ulceration) to grade 4 (deep ulcerations and/or necrotic injury) and patient reported outcomes, regarding pain and difficulties in swallowing, from grade 0 (no pain, nor difficulty in swallowing), grade 1 (soreness but not difficulty in swallowing), grade 2 (moderate pain but able to eat solids), grade 3 (severe pain and not able to eat solids) to grade 4 (extreme pain and unable to oral diet). Evaluation of possible differences between patients receiving trimodal therapy (surgery+chemotherapy+radiotherapy) and patients receiving surgery and radiotherapy but no chemotherapy. | Six weeks during acute cancer treatment. | 
| Time to severe oral mucositis. | Time to severe oral mucositis, grades 3 and 4, as measured by the WHO scale to be assessed during the 6 weeks of oncological treatment. The WHO scale was used to clinically assess oral mucositis grade based on physician observation of mucosa tissue damage from grade 0 (no tissue injury), grade 1 (presence of erythema), grade 2 (presence of ulcers with or without erythema), grade 3 (confluent ulceration) to grade 4 (deep ulcerations and/or necrotic injury) and patient reported outcomes, regarding pain and difficulties in swallowing, from grade 0 (no pain, nor difficulty in swallowing), grade 1 (soreness but not difficulty in swallowing), grade 2 (moderate pain but able to eat solids), grade 3 (severe pain and not able to eat solids) to grade 4 (extreme pain and unable to oral diet). Evaluation of possible differences between patients receiving trimodal therapy (surgery+chemotherapy+radiotherapy) and patients receiving surgery and radiotherapy but no chemotherapy. | Six weeks during acute cancer treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of quality of life perceived by the patient through a PROMs questionnaire, before (baseline) and after 1 month of use of the tested product, starting 6 months after oncological treatment ends. | Comparison of late symptoms throughout the validated Spanish version of the University of Washington Quality of Life questionnaire (UW-QOL) before (baseline) and after 1 month using the tested composition, starting 6 months after oncological treatment ends. The UW-QOL questionnaire consists of 12 single question domains, that have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response. | One month of use of the tested product starting 6 months after oncological treatment ends. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral mucositis, cancer therapy toxic effect, cancer support, pain, ulcers, treatment interruptions, sleep quality, oral mucosa