Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer 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 Phases 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 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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Mucositis; Radiation Toxicity; Chemotherapeutic Toxicity; Oral Mucositis; Saliva; Speech
• Intervention / Treatment: Combination product: Composition comprising olive oil, xylitol and betaine

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge Rodríguez-Vilaboa; Phone Number: +1 855 688 5385; Email: jorge.vilaboa@mucosainnovations.com

Study Locations

• Spain
  • Madrid, Spain, 28023
    • Mucosa Innovations S.L.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of severe oral mucositis in Head & Neck radiated patients with or without chemotherapy.	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.	Six weeks during radiotherapy.
Time to severe oral mucositis in Head & Neck radiated patients with or without chemotherapy.	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.	Six weeks during radiotherapy.
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.	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.	One month of use of the tested product.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between physician's (objective) and patient's (subjective) perception of oral mucositis severity.	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.	Six weeks during radiotherapy.
Frequency of severe oral mucositis (grade 3-4) in patients receiving radiotherapy and patients receiving also chemotherapy.	Frequency of severe oral mucositis (grades 3-4) were to be assessed in patients receiving radiotherapy and patients receiving al chemotherapy.	Six weeks during radiotherapy.
Comparison between oral mucositis severity in patients receiving radiotherapy with patients receiving radiotherapy plus chemotherapy.	Evaluation of possible differences between patients receiving radiotherapy and patients receiving also chemotherapy data was performed.	Six weeks during radiotherapy.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of sleep quality 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.	Sleep quality is assessed with the use of the validated Athens Insomnia Scale PROMs questionnaire in the group of patients enrolled in phase 2 of the study before (baseline) and after 1 month of use of the tested composition, starting 6 months after oncological treatment ends. The Athens Insomnia Scale questionnaire consists of 8 complaint questions that have 4 response options scaled from 0 (best) to 3 (worst).	One month of use of the tested product starting 6 months after oncological treatment ends.

Collaborators and Investigators

• Sponsor: Mucosa Innovations, S.L.
• Investigators: Study Chair: Beatriz Rodríguez-Vilaboa del Cura

Publications and helpful links

General Publications

• Elting LS, Keefe DM, Sonis ST, Garden AS, Spijkervet FK, Barasch A, Tishler RB, Canty TP, Kudrimoti MK, Vera-Llonch M; Burden of Illness Head and Neck Writing Committee. Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy: demonstration of increased frequency, severity, resistance to palliation, and impact on quality of life. Cancer. 2008 Nov 15;113(10):2704-13. doi: 10.1002/cncr.23898.
• 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.
• Rodriguez-Agurto A, Bravo M, Magan-Fernandez A, Lopez-Toruno A, Munoz R, Ferrer J, Mesa F. Randomized clinical trial on the clinical effects of a toothpaste containing extra virgin olive oil, xylitol, and betaine in gingivitis. Sci Rep. 2023 Apr 18;13(1):6294. doi: 10.1038/s41598-023-33521-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Radiotherapy; Chemotherapy; Ulcers; Oral Mucositis; Oral Mucosa; Cancer Therapy Toxic Effect; Cancer Support; Treatment Interruptions
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Lipotropic Agents; Betaine
• Other Study ID Numbers: 02-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No