Topical gel and mouthwash to prevent severe oral mucositis in people receiving head and neck radiation
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.
This will test whether a topical gel and mouthwash (XCM-OM118) can reduce severe oral mucositis and improve quality of life for adults having radiation for head and neck cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mucosa Innovations, S.L. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT05635929 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) with head and neck cancer who are starting radiotherapy (with or without chemotherapy) for the acute phase or adults who completed radiotherapy at least six months ago for the chronic quality-of-life phase, and who can use the products and complete questionnaires.
Not a fit: Patients unlikely to benefit include those unable to properly use the products, those being treated for a different cancer, and chronic-phase patients taking xerostomia drugs such as pilocarpine or cevimeline who are excluded from the protocol.
Why it matters
Potential benefit: If successful, the product could lower rates of severe mucositis, reduce pain and treatment interruptions, and improve swallowing, speech, and overall post-treatment quality of life.
How similar studies have performed: Moisturizing and barrier-type topical approaches have shown symptom relief in small prior studies, but the specific XCM-OM118 composition is novel and not yet widely tested in larger trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid, Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.