Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.

Official title

Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. A Two Phases Study, Part of STOP OM PROJECT. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial.

Overview

The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid) delivered as a gel and a mouthwash is to be studied in regard to its effect on the incidence of severe oral mucositis in Head \& Neck cancer radiated patients. Patient reported outcome measures seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients, being used in this study to assess quality of life of Head \& Neck cancer radiated patients.

Detailed description

This study analyses the severity of oral mucositis in 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 in H\&N cancer patients 6 months after cancer treatment is completed. Quality of life of patients is analyzed before (baseline) and after 1 month period of use of the tested composition beginning 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 PROMS 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 novel composition comprising XCM-OM118 delivered in the form of a topical non-rinsing gel and a mouthwash.

During Phase 1, patients apply two pumps of the gel before bedtime, mid-morning, and mid-afternoon, as well as before and after each therapy session.

Six months after oncological treatment (Phase 2), patients will complete a questionnaire to assess their quality of life before implementing the oral care protocol (baseline). After 1-month intervention, patients will complete a final questionnaire.

This intervention will consist of applying two pumps of the gel before bedtime, mid-morning, and mid-afternoon. Patients will rinse with the mouthwash three times a day, ideally after brushing.

Adverse effects, such as allergic reaction, skin and/or mucosa irritation, itching, discomfort, yeast infection, or any other, will be collected and if so, a detailed description and follow-up of the problem will be noted.

Interventions

• Other XCM-OM118 Composition comprising olive oil, betaine and xylitol
  Topical composition in the form of a gel and a mouthwash.

Primary outcome measures

• Acute-phase 1: Frequency of severe oral mucositis (grades 3-4) in Head & Neck radiated patients (with or without concomitant chemotherapy) using a novel topical composition assessed objectively by the clinician [Time frame: Six weeks during radiotherapy.]
• Chronic-phase 2: Changes in long-term quality of life of radiated Head & Neck cancer patients (with or without concomitant chemotherapy) after 1 month of use of the tested composition. [Time frame: One month of use of the tested product.]

Secondary outcome measures (2)

• Time to onset of severe oral mucositis (grades 3-4) in Head & Neck radiated patients (with or without concomitant chemotherapy) using XCM-OM118, assessed both objectively by the clinician and subjectively reported by the patient. [Time frame: Six weeks during radiotherapy.]
• Comparison between physician's (objective) and patient's (subjective) perception of oral mucositis severity during treatment week by week. [Time frame: Six weeks during radiotherapy.]

Eligibility criteria

Inclusion criteria

Acute Phase

• Patients diagnosed with Head \& Neck cancer who will undergo radiotherapy (with or without concomitant chemotherapy)
• Patients who are able to read, understand, and complete the questionnaire.
• Patients over 18 years of age.

Chronic Phase

• Patients who have completed radiotherapy treatment at least 6 months before study enrollement.
• Patients who are able to read, understand, and complete the questionnaire.
• Patients over 18 years of age.

Exclusion criteria

Acute Phase

• Patients who are unable to properly use the products.
• Patients who do not consent to participate in the study.
• Patients who were being treated for another type of cancer.

Chronic Phase

• Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.
• Patients who do not consent to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Spain · 1 center

• Mucosa Innovations S.L. — Madrid

Publications

• 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. PMID 37072503
• 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. PMID 21109081
• 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 quali PMID 18973181

Identifiers

NCT: NCT05635929 · STOPOM01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗