Clinical trial · Interventional
Efficacy Study of Mepitel Film the Prophylaxis of Radiation-Induced Skin Reactions in Breast Cancer Patients
An Efficacy Study of Mepitel Film in the Prophylaxis of Radiation-Induced Skin Reactions in Breast Cancer Patients Undergoing Adjuvant Radiotherapy
- 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)
In patients undergoing adjuvant radiotherapy for breast cancer, radiation-induced skin toxicities are a common occurrence and adversely impact patients' quality of life (QOL). In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. Recently, a phase III randomized trial by Herst et al. (n=78) in New Zealand showed that the prophylactic use of Mepitel Film reduced skin reaction severity by 92% compared to skin treated only with aqueous cream. Mepitel film has not been widely adopted in North America. To validate the efficacy of the film and guide the development of a larger multi-centre phase II study, a pilot study testing the efficacy of the film is proposed. In the study, 30 patients will have the film applied on their breast for the duration of radiation treatment and their skin reactions will be assessed throughout the treatment and after the treatment. The investigators hypothesize that the severity and incidence rates of skin reactions for patients using Mepitel film will be lower when compared to real world data from our centre, and that cosmetic outcomes will be improved with the film.
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 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mepitel Film Arm
- description
- This is a single arm trial where all patients will receive the intervention of Mepitel Film.
- interventionNames
- Other: Mepitel Film
Primary outcomes (1)
- measure
- Observable differences between treated and non-treated breasts/chest wall
- timeFrame
- Within 3 months following radiation
- description
- Determined by a cosmetic dermatologist from photographs of the treated and non-treated breast/chest wall.
Secondary outcomes (12)
- measure
- Patient reports of acute skin toxicity
- timeFrame
- Within 3 months following radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * Patient will receive adjuvant breast or chest wall radiation * Post-lumpectomy patients with band size of at least 36 inches or cup size of D or larger will be part of the large breast cohort * Post-lumpectomy patients that do not meet this size requirement will be part of the small or medium sized breast cohort * Post-mastectomy patients are part of the chest wall radiation cohort * Can communicate in English or be aided by a hospital translator Exclusion Criteria: * Patient had previous radiation therapy to the treatment area * Patient had breast reconstruction * Patient has a Karnofsky Performance Status score \<70 * Patient will have radiation treatment in prone or reverse decubitus positions * Patient will receive partial breast external beam radiation or brachytherapy * Patient will receive radiation to the supraclavicular region
References
Publications (0)
Data not yet available