Clinical trial · Interventional
Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Breast Cancer Patients
A Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment
- 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)
Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin reactions which adversely impact quality of life. Importantly, patients receiving chest wall radiation or patients with large breasts are more likely to have worse skin reactions. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. In response to the lack of evidence, Sunnybrook investigators previously conducted a pilot study (REB #294-2018) of Mepitel Film and preliminary results showed improvements in high grade skin reactions. Mepitel Film has not been widely adopted in North America as more evidence is needed. The validate the efficacy of the film compared to the standard of care, a study testing the efficacy of the film is proposed. In the study, 216 patients will be randomized (2:1) to receive either the film or the institution's current skin treatments and all patients will have their skin assessed.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mepitel Film | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mepitel Film Arm
- description
- Patients randomized to the Mepitel Film arm will receive the film for the entire duration of their radiation treatment and will be worn up to 2 weeks after completion of radiotherapy.
- interventionNames
- Device: Mepitel Film
- type
- NO_INTERVENTION
- label
- Standard of Care Arm
- description
- Patients randomized to the Standard of Care arm will be instructed to use the institutional standard of care skin treatments for the entire duration of their radiation treatment and up to 2 weeks after completion of radiotherapy.
Primary outcomes (1)
- measure
- Number of participants with treatment-related radiation-induced skin toxicity as assessed by the CTCAE v.5.0.
- timeFrame
- Within 3 months following radiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Male or female. * Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes. * Patients have undergone a mastectomy with or without reconstruction. * Patients with large breasts \[bra size 36 in and/or C cup or greater\] and have undergone breast-conserving surgery. * Patients are scheduled to receive conventionally- (50Gy/25#) or hypo-fractionated (42.56Gy/16#) photon-based radiation. * Patients treated with or without the addition of tissue equivalent bolus or boost. Exclusion Criteria: * Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation. * Prior radiotherapy to any portion of the planned treatment site. * Active rash or pre-existing dermatitis within the treatment field. * Known prior history of adhesive, tape or silicon allergy or sensitivity. * Concomitant cytotoxic chemotherapy. * Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy. * Karnofsky Performance Status \< 60.
References
Publications (1)
- DERIVEDBehroozian T, Milton L, Karam I, Zhang L, Ding K, Lou J, Gallant F, Rakovitch E, Tran W, Soliman H, Leung E, Vesprini D, Szumacher E, Chen H, Donovan E, Lam J, Spadafora S, Wronski M, Lavoie C, Walde N, Lam E, Wong G, McKenzie E, Ariello K, Kennedy S, Shariati S, Carothers K, Gonzales G, Kagan Y, Chow E. Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial. J Clin Oncol. 2023 Feb 20;41(6):1250-1264. doi: 10.1200/JCO.22.01873. Epub 2022 Dec 9. PMID 36493331