NCT05635929Recruiting
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.
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 8 Nov 2022
- Start date
- 11 Oct 2022
- Primary completion date
- Mar 2027
- Lead sponsor
- Mucosa Innovations, S.L.
- Diseases
- Head and neck cancer
- NCT number
- NCT05635929
What you commit to
- Study type: Interventional
- Planned participants: 63
- From 11 Oct 2022 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.
Other illness
- Patients who were being treated for another type of cancer.
- Chronic Phase
Other
- Acute Phase
- Patients who are unable to properly use the products.
- Patients who do not consent to participate in the study.
- Patients who do not consent to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mucosa Innovations S.L. Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.