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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.

NCT05635929 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

Interventions

OTHER

XCM-OM118 Composition comprising olive oil, betaine and xylitol

Topical composition in the form of a gel and a mouthwash.

Sponsors & Collaborators

  • HM Sanchinarro University Hospital

    collaborator OTHER

  • Mucosa Innovations, S.L.

    lead INDUSTRY

Principal Investigators

  • Beatriz Rodríguez-Vilaboa del Cura

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05635929 on ClinicalTrials.gov