Mepitel Film Breast (NCT07729423) | Clinical Trial Compass
RecruitingNot Applicable
Mepitel Film Breast
Singapore60 participantsStarted 2025-11-12
Plain-language summary
Primary Objective To examine the tolerability of Mepitel Film in the prevention of RD patients undergoing whole breast or chest wall RT in the hot and humid weather in Singapore
Secondary Objectives To evaluate the incidence of acute radiation dermatitis, quality of life, satisfaction, and cost analysis of Mepitel Film use.
Who can participate
Age range
21 Years – 100 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:
* Age ≥ 21 years old (legal age of maturity in Singapore)
* Male or female
* Informed consent
* Patients have undergone a mastectomy with or without reconstruction or breast-conserving surgery.
* Histological confirmation of breast carcinoma (invasive or in situ carcinoma)
* Patients are scheduled to receive hypofractionated (40Gy in 15 daily fractions or 26Gy in 5 daily fractions) photon-based RT
* Patient treated with or without tissue the addition of equivalent bolus and/or boost.
* Can communicate in English or be aided by a translator.
Exclusion Criteria:
* Prior RT to any portion of the planned treatment site.
* Patients will receive partial breast external beam RT, proton beam therapy, or brachytherapy.
* Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area may make skin assessment for the study difficult per treating physician discretion.
* Known history of adhesive, tape or silicon allergy or sensitivity.
* Concomitant cytotoxic chemotherapy
* Bilateral breast pathology requiring concurrent bilateral breast or chest wall RT.
* Current inflammatory breast cancer or gross dermal involvement at initiation of RT.
* Patient has a Karnofsky Performance Status score \<60.
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
Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada
Timeframe: From first day RT to the 2 weeks post RT