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.

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

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.

Conditions10

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