Mepitel Film Breast

National University Hospital, Singapore60 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Radiation Dermatitis

Eligibility

Sex: ALLMin age: 21 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

National University Hospital

Singapore, Singapore

RECRUITING

Outcomes

Primary Outcomes

Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada

Time frame: From first day RT to the 2 weeks post RT

Secondary Outcomes

Frequency and severity of patient reported pruritis in SSA and RISRAS related to use of Mepitel Film when compared with the data from the RCT in Ontario, Canada

Time frame: From enrollment to the 3 months post RT

Incidence of ARD grades 2 to 3, as defined by the CTCAE V5 assessed by HCP

Time frame: From enrollment to the 2 weeks post RT

Patient-reported skin-related symptoms using the Skin Symptom Assessment (SSA)

Time frame: From enrollment to the end of study (2 years post RT)

HCP reported SSA

Time frame: From enrollment to the end of study (2 years post RT)

Incidence of moist desquamation assessed by HCP

Time frame: From enrollment to 2 weeks post RT

Radiation-Induced Skin Reaction Assessment Scale (RISRAS) assessed by patient and HCP

Time frame: From enrollment to 3 months post RT

Blinded HCP-assessed mRISRAS scores from blinded grading of photographs taken at the end of RT

Time frame: End of RT treatment

Photographs with EORTC-BCRS

Time frame: From enrollment to the end of study (2 years post RT)

Patient-reported QOL using the Skindex-16

Central Contacts

Shing Fung Lee, MBBS

CONTACT

+6567726392 leesf@nuhs.edu.sg

Qian Yee Chai, BSc

CONTACT

+6567723077 queenie_qy_chai@nuhs.edu.sg

Data from ClinicalTrials.gov

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