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.
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.
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.
Single group
XCM-OM118 Composition comprising olive oil, betaine and xylitol
Other interventionTopical composition in the form of a gel and a mouthwash.
Acute-phase 1: Frequency of severe oral mucositis (grades 3-4) in Head & Neck radiated patients (with or without concomitant chemotherapy) using a novel topical composition assessed objectively by the clinician
Frequency of severe oral mucositis (grades 3-4) measured with the World Health Organization (WHO) mucositis scale, assessed at weekly intervals during 6 weeks of radiotherapy. Oral mucositis will be objectively assessed by clinician, based on observation of mucosa tissue damage, pain and difficulties in swallowing from grade 0 to 4, where grade 0 is the best health score and grade 4 is the worst health score. Precisely, grade 0 means no tissue injury nor pain nor difficulty in swallowing, grade 1 means presence of erythema, soreness but not difficulty in swallowing, grade 2 means presence of ulcers with or without erythema, moderate pain but able to eat solids, grade 3 means confluent ulceration with severe pain and not able to eat solids and grade 4 means deep ulcerations and/or necrotic injury, extreme pain and unable to eat solids/drink. Grades 3 and 4 are defined as severe oral mucositis (SOM).
Chronic-phase 2: Changes in long-term quality of life of radiated Head & Neck cancer patients (with or without concomitant chemotherapy) after 1 month of use of the tested composition.
Comparison of late symptoms perceived by the patient through the PROMs validated Spanish version of the University of Washington Quality of Life questionnaire (UW-QOL) before (baseline) and after 1 month using the tested composition, starting 6 months after radiotherapy completion. The UW-QOL questionnaire will be filled by patients at baseline and after 1 month of use of the tested composition where the possible response options (from 3 to 6) to the 12 single question domains, are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response.
Time to onset of severe oral mucositis (grades 3-4) in Head & Neck radiated patients (with or without concomitant chemotherapy) using XCM-OM118, assessed both objectively by the clinician and subjectively reported by the patient.
Time to onset of severe oral mucositis (grades 3-4) determined through both objective clinical assessments and patient-reported subjective symptoms, along the 6 weeks of radiotherapy.
Comparison between physician's (objective) and patient's (subjective) perception of oral mucositis severity during treatment week by week.
WHO scale will be used by clinician to objectively assess oral mucositis (OM) based on physician's observation of mucosa tissue damage, pain and difficulties in swallowing (grade 0 to grade 4) along 6 weeks of radiotherapy (RT). Patient reported outcomes, regarding pain and difficulties in swallowing, from grade 0 (no pain, nor difficulty in swallowing), 1 (soreness but not difficulty in swallowing), 2 (moderate pain but able to eat solids), 3 (severe pain and not able to eat solids) to grade 4 (extreme pain and unable to oral diet), will be recovered during an interview at time of visit to the unit at weekly intervals along the 6 weeks of RT. Evaluation of possible differences between objective and subjective OM severity data will be performed by calculating the agreement proportion and the Spearman´s rho coefficient.
Comparison of oral mucositis severity in patients receiving radiotherapy vs patients receiving radiotherapy plus chemotherapy, with both groups using a novel topical composition
Oral mucositis severity will be assessed in patients receiving radiotherapy vs patients receiving radiotherapy plus chemotherapy using both objective evaluations. Oral mucositis will be objectively assessed by clinician, based on observation of mucosa tissue damage, pain and difficulties in swallowing, from grade 0 (no tissue injury, no pain, nor difficulty in swallowing), grade 1 (presence of erythema, soreness but not difficulty in swallowing), grade 2 (presence of ulcers with or without erythema, moderate pain but able to eat solids), grade 3 (confluent ulceration, severe pain and not able to eat solids) to grade 4 (deep ulcerations and/or necrotic injury, extreme pain and unable to oral diet) at weekly intervals along the 6 weeks of radiotherapy.
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Mucosa Innovations, S.L.
Lead sponsor
HM Sanchinarro University Hospital
Collaborator
