Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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.

Led by Mucosa Innovations, S.L. · Updated on 2026-04-15

63

Participants Needed

1

Research Sites

228 weeks

Total Duration

On this page

Sponsors

M

Mucosa Innovations, S.L.

Lead Sponsor

H

HM Sanchinarro University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official 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.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Patients who have completed radiotherapy treatment at least 6 months before study enrolment (for chronic phase)
Not Eligible

You will not qualify if you...

  • 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 (acute phase)
  • Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia (chronic phase)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mucosa Innovations S.L.

Madrid, Madrid, Spain, 28023

Actively Recruiting

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Research Team

J

Jorge Rodríguez-Vilaboa

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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