Recruiting
Mepitel Film Breast
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.
ClinicalTrials.gov IDNCT07729423
PhaseNot Applicable
Enrollment60
SponsorNational University Hospital, Singapore
Age21 Years
SexALL
Conditions studied
Breast Cancer, Radiation Dermatitis
About this study
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.
Primary outcomes
- Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada (From first day RT to the 2 weeks post RT)
Eligibility information
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.
Study locations
- National University Hospital, Singapore, Singapore
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.