Effect of a Novel Topical Composition (XCM-0M118) on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.
NCT ID: NCT05635929
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2022-10-11
2024-01-11
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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 simple questionnaire.
XCM-OM118 Composition comprising olive oil, betaine and xylitol
Topical composition in the form of a gel and a mouthwash.
QoL in HNC was assessed 6 months after therapy 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.
XCM-OM118 Composition comprising olive oil, betaine and xylitol
Topical composition in the form of a gel and a mouthwash.
Interventions
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XCM-OM118 Composition comprising olive oil, betaine and xylitol
Topical composition in the form of a gel and a mouthwash.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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HM Sanchinarro University Hospital
OTHER
Mucosa Innovations, S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Beatriz RodrÃguez-Vilaboa del Cura
Role: STUDY_CHAIR
Locations
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Mucosa Innovations S.L.
Madrid, Madrid, Spain
Countries
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References
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Rodriguez-Agurto A, Bravo M, Magan-Fernandez A, Lopez-Toruno A, Munoz R, Ferrer J, Mesa F. Randomized clinical trial on the clinical effects of a toothpaste containing extra virgin olive oil, xylitol, and betaine in gingivitis. Sci Rep. 2023 Apr 18;13(1):6294. doi: 10.1038/s41598-023-33521-4.
Nazar G, Garmendia ML, Royer M, McDowell JA, Weymuller EA Jr, Yueh B. Spanish validation of the University of Washington Quality of Life questionnaire for head and neck cancer patients. Otolaryngol Head Neck Surg. 2010 Dec;143(6):801-7, 807.e1-2. doi: 10.1016/j.otohns.2010.08.008.
Elting LS, Keefe DM, Sonis ST, Garden AS, Spijkervet FK, Barasch A, Tishler RB, Canty TP, Kudrimoti MK, Vera-Llonch M; Burden of Illness Head and Neck Writing Committee. Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy: demonstration of increased frequency, severity, resistance to palliation, and impact on quality of life. Cancer. 2008 Nov 15;113(10):2704-13. doi: 10.1002/cncr.23898.
Other Identifiers
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STOPOM01
Identifier Type: -
Identifier Source: org_study_id