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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.

RecruitingNAAges 18 Years - anyAllMucosa Innovations, S.L.
NCT05635929 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

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

1 site
Mucosa Innovations S.L.
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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