Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Breast Cancer Patients

NCT04166799 | Active Not Recruiting

• 1 other identifier: Mepitel RCT
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Radiation Dermatitis

Keywords

Barrier Film; Mepitel; Quality of life; Radiation Dermatitis; Skin toxicity

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related radiation-induced skin toxicity as assessed by the CTCAE v.5.0.

  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.

  Within 3 months following radiation

Secondary Outcomes (5)

• Number of participants with acute radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.

  Within 3 months following radiotherapy

• Number of participants with acute radiation-induced skin toxicities as assessed by the participant using the CTCAE v5.0.

  Within 3 months following radiotherapy

• Number of participants with late radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.

  6, 12 and 24 months following radiotherapy

• Number of participants with late radiation-induced skin toxicities as assessed by the participant using the CTCAE v5.0.

  6, 12 and 24 months following radiotherapy

• Number of participants with reconstruction complications as assessed by the BREAST-Q PROMS modules for breast-conserving therapy and reconstruction.

  12 and 24 months post-radiotherapy

Study Arms (2)

Mepitel Film Arm

EXPERIMENTAL

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.

Device: Mepitel Film

Standard of Care Arm

NO INTERVENTION

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.

Interventions

Mepitel Film DEVICE

Mepitel® Film is a thin, soft and conformable transparent film dressing with Safetac®, offering protection for vulnerable skin.

Mepitel Film Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Behroozian 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Study Officials

• Edward LW Chow, MBBS

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator with Dr. Irene Karam [ikaram]

Model Details: Patients receiving chest wall radiation or patients with large breast size (bra size 36 in and/or C cup or greater) will be randomized 2:1 to receive either Mepitel Film or the institutional standard of care skin treatments.

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 18, 2019
• Study Start: January 30, 2020
• Primary Completion: August 20, 2024
• Study Completion: December 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)