Gel and mouthwash for mouth sores in head and neck cancer radiation
Tests a gel and mouthwash for severe mouth sores in radiated head and neck cancer.
Plain-language title generated from the registry record
Registry 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.
Key facts
- Where
- Madrid, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with head and neck cancer who will have, or have finished, radiotherapy. It tests a gel and mouthwash against oral mucositis (mouth sores).
- Age
- Over 18 years old.
- Sex
- Women and men can join.
- Disease stage
- Head and neck cancer. Acute phase: radiotherapy is still to come, with or without chemotherapy. Chronic phase: radiotherapy finished at least 6 months before enrolment.
- Earlier treatment
- Acute phase: radiotherapy planned. Chronic phase: radiotherapy completed at least 6 months before joining.
Main reasons for not taking part
- Cannot properly use the products (acute phase)
- Being treated for another type of cancer (acute phase)
- Using medicines such as pilocarpine or cevimeline for dry mouth (chronic phase)
- Cannot read, understand and complete the questionnaire
- Does not consent to take part
Read by machine on 12 November 2026.
Where in Spain
- Mucosa Innovations S.L.Madrid, SpainContact: Jorge Rodríguez-VilaboaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Mucosa Innovations, S.L.
- Trial code
- NCT05635929
- Record updated
- 15 April 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia; Patients who were being treated for another type of cancer; Chronic Phase; 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.