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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMucosa Innovations, S.L.

About this 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.

Eligibility criteria

Qualifiers

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 enrollement.

Disqualifiers

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.

Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.

Trial design

Treatments tested in this trial

  • XCM-OM118 Composition comprising olive oil, betaine and xylitol

Treatment groups

63 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mucosa Innovations, S.L.

Lead sponsor

HM Sanchinarro University Hospital

Collaborator