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.

NCT05635929 | Recruiting

• 1 other identifier: STOPOM01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Saliva; Radiation Toxicity; Chemotherapeutic Toxicity; Head and Neck Cancer; Oral Mucositis; Quality of Life; Mucositis; Pain; Speech

Keywords

Oral Mucositis; Cancer Therapy Toxic Effect; Cancer Support; Pain; Ulcers; Treatment Interruptions; Oral Mucosa; Radiotherapy; Chemotherapy; Head and Neck Cancer; Severe Oral Mucositis

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  One month of use of the tested product.

Secondary Outcomes (2)

• 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.

  Six weeks during radiotherapy.

• Comparison between physician's (objective) and patient's (subjective) perception of oral mucositis severity during treatment week by week.

  Six weeks during radiotherapy.

Other Outcomes (1)

• Comparison of oral mucositis severity in patients receiving radiotherapy vs patients receiving radiotherapy plus chemotherapy, with both groups using a novel topical composition

  Six weeks during radiotherapy.

Study Arms (1)

Acute and Chronic outcomes in radiotherapy treated HNC patients using XCM-OM118.

EXPERIMENTAL

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

Interventions

XCM-OM118 Composition comprising olive oil, betaine and xylitol OTHER

Topical composition in the form of a gel and a mouthwash.

Acute and Chronic outcomes in radiotherapy treated HNC patients using XCM-OM118.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mucosa Innovations, S.L.: lead
• HM Sanchinarro University Hospital: collaborator

Study Sites (1)

Mucosa Innovations S.L.

Madrid, Madrid, 28023, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 37072503 BACKGROUND

• 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.

  PMID: 21109081 RESULT

• 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.

  PMID: 18973181 RESULT

MeSH Terms

Conditions

Stomatitis; Mucositis; Pain; Speech; Radiation Injuries; Head and Neck Neoplasms; Ulcer

Interventions

Betaine; Xylitol

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior; Wounds and Injuries; Neoplasms by Site; Neoplasms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• Beatriz Rodríguez-Vilaboa del Cura

  STUDY CHAIR

Central Study Contacts

Jorge Rodríguez-Vilaboa

CONTACT

+34 629 288 597; jorge.vilaboa@mucosainnovations.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group, interventional, open-label study.

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 2, 2022
• Study Start: October 11, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)