Mepitel Film: Mepitel® Film is a thin, soft and conformable transparent film dressing with Safetac®, offering protection for vulnerable skin.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Number of participants with treatment-related radiation-induced skin toxicity as assessed by the CTCAE v.5.0. — Within 3 months following radiation Number of participants with radiation-induced skin toxicities as assessed by the Common Terminology Criteria for Adverse Events v.5.0, comparing changes in the treated versus non-treated breast or chest wall from baseline to weekly during radiation treatment and once a week for 6 weeks post-treatment.
Trial sites (1)
Facility
City
Region
Status
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto
Ontario
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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