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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05635929
• Other study ID #: 02-2022
• Status: Completed
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: September 11, 2023

Study information

• Verified date: January 2024
• Source: Mucosa Innovations, S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 11, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity
• Mucositis
• Oral Mucositis
• Pain
• Quality of Life
• Radiation Toxicity
• Saliva
• Speech
• Stomatitis

Intervention

Combination Product:
• Composition comprising olive oil, xylitol and betaine
Topical composition in the form of a gel.

Locations

Country	Name	City	State
Spain	Mucosa Innovations S.L.	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Mucosa Innovations, S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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 trea — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.