Overview
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.
Description
This prospective, observational feasibility study will enroll 60 breast cancer patients, divided into two cohorts: 30 receiving local breast RT and 30 receiving chest wall RT post-mastectomy. We hypothesize that Mepitel Film will be well-tolerated and effective in preventing severe RD (Grade ≥2) in this population, with results compared to published data from Western countries. Previous randomized controlled trials (RCTs) conducted in regions with low humidity and cool temperatures have raised concerns about film adherence and cost in tropical climates. Therefore, assessing the efficacy of Mepitel Film in a hot and humid environment is warranted.
Eligibility
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.
