Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.
- Conditions
- SpeechChemotherapeutic ToxicityQuality of LifeSalivaRadiation ToxicityOral MucositisMucositisPain
- Interventions
- Combination Product: Composition comprising olive oil, xylitol and betaine
- Registration Number
- NCT05635929
- Lead Sponsor
- Mucosa Innovations, S.L.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- Patients with diagnose of Head & Neck cancer that are going to receive cancer therapy (radio and/or chemotherapy).
- Patients taking drugs for xerostomia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chronic group (Phase 2) Composition comprising olive oil, xylitol and betaine Patients 6 months after oncological treatment is finished Acute group (Phase 1) Composition comprising olive oil, xylitol and betaine Patients during radiotherapy
- Primary Outcome Measures
Name Time Method Time to severe oral mucositis in Head & Neck radiated patients with or without chemotherapy. Six weeks during radiotherapy. Time to severe oral mucositis (grades 3-4) was analysed from clinically objective data and also from patient reported subjective symptoms registered week per week.
Frequency of severe oral mucositis in Head & Neck radiated patients with or without chemotherapy. Six weeks during radiotherapy. Frequency of severe oral mucositis (grades 3-4) measured with the WHO scale during the 6 weeks of radiotherapy.
Oral mucositis was objectively assessed by clinician, based on 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) at weekly intervals along the 6 weeks of radiotherapy.
Subjective assessment was also measured from 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) at the same time as the clinician measurement.
Frequency of severe oral mucositis (grades 3-4) were analysed at the end of the treatment.Quality of life evaluation of radiotherapy, with or without chemotherapy, long-term symptoms (6 months) after 1 month of use of the tested composition in head & neck cancer patients. One month of use of the tested product. Comparison of late symptoms perceived by the patient through the PROMs 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 radiotherapy completion.
The UW-QOL questionnaire was filled by patients at baseline and after 1 month of use of the tested composition where the possible response options (from 3 to 6) to the 12 single question domains, were scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response.
- Secondary Outcome Measures
Name Time Method Comparison between physician's (objective) and patient's (subjective) perception of oral mucositis severity. Six weeks during radiotherapy. The WHO scale was used by clinician to objectively assess oral mucositis grade based on physician's observation of mucosa tissue damage along the 6 weeks of radiotherapy. Oral mucositis severity was graded 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). 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), were recovered during an interview at time of visit to the unit at weekly intervals along the 6 weeks of radiotherapy.
Evaluation of possible differences between objective and subjective data was performed.Frequency of severe oral mucositis (grade 3-4) in patients receiving radiotherapy and patients receiving also chemotherapy. Six weeks during radiotherapy. Frequency of severe oral mucositis (grades 3-4) were to be assessed in patients receiving radiotherapy and patients receiving al chemotherapy.
Comparison between oral mucositis severity in patients receiving radiotherapy with patients receiving radiotherapy plus chemotherapy. Six weeks during radiotherapy. Evaluation of possible differences between patients receiving radiotherapy and patients receiving also chemotherapy data was performed.
Trial Locations
- Locations (1)
Mucosa Innovations S.L.
🇪🇸Madrid, Spain