Clinical trial NCT05635929: Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Quality of Life
Mucositis
Pain
Speech
Saliva
Radiation Toxicity
Chemotherapeutic Toxicity
Keywords: Oral Mucositis
Cancer Therapy Toxic Effect
Cancer Support
Pain
Ulcers
Treatment Interruptions
Oral Mucosa
Radiotherapy
Chemotherapy
Lead sponsor: Mucosa Innovations, S.L.
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single group, interventional, open-label study.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Frequency of severe oral mucositis in Head & Neck radiated patients with or without chemotherapy.
timeFrame: Six weeks during radiotherapy.
measure: Time to severe oral mucositis in Head & Neck radiated patients with or without chemotherapy.
timeFrame: Six weeks during radiotherapy.
measure: 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.
timeFrame: One month of use of the tested product.
Secondary outcomes:
measure: Comparison between physician's (objective) and patient's (subjective) perception of oral mucositis severity.
timeFrame: Six weeks during radiotherapy.
measure: Frequency of severe oral mucositis (grade 3-4) in patients receiving radiotherapy and patients receiving also chemotherapy.
timeFrame: Six weeks during radiotherapy.
measure: Comparison between oral mucositis severity in patients receiving radiotherapy with patients receiving radiotherapy plus chemotherapy.
timeFrame: Six weeks during radiotherapy.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Mucosa Innovations S.L.
Study officials:
name: Beatriz Rodríguez-Vilaboa del Cura
role: STUDY_CHAIR
References:
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.
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: 10.1016/j.otohns.2010.08.008.
citation: 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.