Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Ca… (NCT05635929) | Clinical Trial Compass
RecruitingNot Applicable
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.
Spain63 participantsStarted 2022-10-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: Six weeks during radiotherapy.
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.
Timeframe: One month of use of the tested product.