NCT05635929 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.
| NCT ID | NCT05635929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mucosa Innovations, S.L. |
| Condition | Oral Mucositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2022-10-11 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 63 participants in total. It began in 2022-10-11 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Beatriz Rodríguez-Vilaboa del Cura
STUDY CHAIR
Frequently Asked Questions
Who can join the NCT05635929 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05635929 currently recruiting?
Yes, NCT05635929 is actively recruiting participants. Contact the research team at jorge.vilaboa@mucosainnovations.com for enrollment information.
Where is the NCT05635929 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT05635929 clinical trial?
NCT05635929 is sponsored by Mucosa Innovations, S.L.. The principal investigator is Beatriz Rodríguez-Vilaboa del Cura. The trial plans to enroll 63 participants.