Clinical trial · Observational
Mepitel Film Breast
The Tolerability of Mepitel Film for the Prevention of Radiation Dermatitis in Breast Cancer Patients in Hot Weather: A Feasibility Study
NCT07729423CI-TRIAL-00119428recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients with breast radiation
- label
- Patients with chest wall radiation
Primary outcomes (1)
- measure
- 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
Secondary outcomes (12)
- measure
- 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
- timeFrame
- From enrollment to the 3 months post RT
- measure
- Incidence of ARD grades 2 to 3, as defined by the CTCAE V5 assessed by HCP
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.