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NCT Number: NCT05635929

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.

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.

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Key information

Conditions

Oral Mucositis Behavior Chemotherapeutic Toxicity Communication Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Mucositis Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Radiation Injuries Radiation Toxicity Saliva Signs and Symptoms Speech Stomatitis Stomatognathic Diseases Ulcer Verbal Behavior Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mucosa Innovations S.L.

Madrid, 28023, Spain

Location status: Recruiting

Location contact

Jorge Rodríguez-Vilaboa

CONTACT

+34 629 288 597

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

XCM-OM118 Composition comprising olive oil, betaine and xylitol

Other

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

Primary outcomes

  1. 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

    Time frame: Six weeks during radiotherapy.

    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).

  2. 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.

    Time frame: One month of use of the tested product.

    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.

Secondary outcomes

  1. 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 frame: Six weeks during radiotherapy.

    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.

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

    Time frame: Six weeks during radiotherapy.

    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.

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

    Time frame: Six weeks during radiotherapy.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jorge Rodríguez-Vilaboa

CONTACT

[email protected]

+34 629 288 597

Sponsors and collaborators

Lead sponsor

Mucosa Innovations, S.L.

Industry

Collaborators

  • HM Sanchinarro University Hospital

Registry information

Official study title

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. A Two Phases Study, Part of STOP OM PROJECT. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial.

Acronym: STOPOMP

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2022
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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