Topical gel and mouthwash to prevent severe oral mucositis in people receiving head and neck radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The intervention uses a novel topical composition (XCM-OM118: olive oil, betaine, xylitol and other components) delivered as a non-rinsing gel and a mouthwash applied multiple times daily during radiotherapy and in a separate chronic phase. Phase 1 follows patients through the first six weeks of radiotherapy (with or without chemotherapy) to record incidence and severity of oral mucositis using the WHO scale plus structured patient-reported symptom questionnaires. Phase 2 enrolls patients at least six months after completing radiotherapy to record baseline quality of life using the University of Washington PROMs, then gives the oral regimen for one month and repeats the PROMs. Mucosa management is standardized across participants and outcomes focus on mucositis severity, pain, swallowing/speech effects, and PROMs-measured quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Jorge Rodríguez-Vilaboa
• Email: jorge.vilaboa@mucosainnovations.com
• Phone: +34 629 288 597

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.