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.

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.

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.

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.

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.