An interventional study of XCM-OM118 Composition comprising olive oil, betaine and xylitol in Oral Mucositis, Quality of Life and Mucositis, sponsored by Mucosa Innovations, S.L.. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Mucosa Innovations, S.L. · Not applicable, Interventional, and Prevention
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.
This study analyses the severity of oral mucositis in H\&N cancer patients along the first 6 weeks of radiotherapy with or without chemotherapy (Phase 1).
Phase 2 evaluates Quality of Life in a pool in H\&N cancer patients 6 months after cancer treatment is completed. Quality of life of patients is analyzed before (baseline) and after 1 month period of use of the tested composition beginning 6 months after oncological treatment completion.
During cancer treatment (Phase 1), mucositis may affect the course of therapy and long-term survival, while after treatment (Phase 2) chronic pain, xerostomia, dysphagia and speech limitations between others are behind anxiety and poor quality of life.
The WHO oral mucositis scale together with a structured qualitative questionnaire to recover patient reported symptoms are used during phase 1.
A validated Quality of Life PROMS questionnaire described by the University of Washington, is chosen for Phase 2 evaluation.
Oral mucosa management is homogenized both during acute and chronic phase with the use of a novel composition comprising XCM-OM118 delivered in the form of a topical non-rinsing gel and a mouthwash.
During Phase 1, patients apply two pumps of the gel before bedtime, mid-morning, and mid-afternoon, as well as before and after each therapy session.
Six months after oncological treatment (Phase 2), patients will complete a questionnaire to assess their quality of life before implementing the oral care protocol (baseline). After 1-month intervention, patients will complete a final questionnaire.
This intervention will consist of applying two pumps of the gel before bedtime, mid-morning, and mid-afternoon. Patients will rinse with the mouthwash three times a day, ideally after brushing.
Adverse effects, such as allergic reaction, skin and/or mucosa irritation, itching, discomfort, yeast infection, or any other, will be collected and if so, a detailed description and follow-up of the problem will be noted.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 63 is close to the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Mucosa Innovations, S.L. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Acute Phase
Chronic Phase
Exclusion Criteria:
Acute Phase
Chronic Phase
Incidence and time to onset of severe oral mucositis during radiotherapy for HNC (Acute-phase 1). Oral Mucositis in Head and Neck cancer patients using XCM-OM118 during radiotherapy was assessed by the clinician once weekly using the WHO scale and severity, if any, was graded from 0 to 4. Incidence and time to onset of severe oral mucositis were determined. Patient reported outcomes regarding their oral mucositis experience (pain and functional impairment) were collected through a questionnaire. QoL in HNC was assessed 6 months after radiotherapy and 1 month of use of XCM-OM118 (Chronic-phase 2). Patients who had completed oncological treatment six months earlier used the XCM-OM118 composition for one month. Quality of life was assessed at baseline and after the intervention using the University of Washington Quality of Life (UW-QOL) PROMs questionnaire, which measures domains including pain, appearance, and personal activity. Baseline scores were compared with final PROMs scores.
Other: XCM-OM118 Composition comprising olive oil, betaine and xylitol
Topical 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).
Time frame: Six weeks during radiotherapy.
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 frame: One month of use of the tested product.
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.
Time frame: Six weeks during 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.
Time frame: Six weeks during radiotherapy.
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.
Time frame: Six weeks during radiotherapy.
Plan to share: No
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Mucosa Innovations, S.L.