Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy

Alliance for Clinical Trials in Oncology

Status and phase: Active, not recruiting; Phase 3

Conditions: Breast Carcinoma; Mastectomy Patient

Treatments: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Best Practice; Device: Wound Dressing Material

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04989504

NCI-2019-04688 (Registry Identifier)

UG1CA189823 (U.S. NIH Grant/Contract)

A221803

Details and patient eligibility

About

This phase III trial studies how well Mepitel Film works in reducing radiation dermatitis (redness and peeling) in patients with breast cancer during radiation therapy after a mastectomy. Mepitel Film may reduce the severity of skin redness and peeling in the area of radiation.

Full description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. To determine the ability of Mepitel Film to reduce the severity of radiation dermatitis in patients undergoing post-mastectomy radiotherapy for breast cancer when compared to the institutional standard of care.

KEY SECONDARY OBJECTIVES:

I. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a centralized, blinded provider assessment review of photographs.

II. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a non-blinded institutional provider assessment.

III. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a combined patient and non-blinded institutional provider assessment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care skin management during radiation therapy for up to 6 weeks.

ARM II: Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.

After completion of study, patients are followed up at 7-14 days, 3 months, 6 months, 1 year, and 2 years.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Histologic confirmation of breast malignancy with TNM staging.
• Patients must have undergone a mastectomy with or without reconstruction within the past 120 days if not receiving adjuvant therapy, or within 60 days after completion of the last dose of chemotherapy.
• No prior radiotherapy to any portion of the planned treatment site.
• No documented history of adhesive or tape allergy.
• Patients must be scheduled to receive conventionally fractionated photon-based radiation. Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation or hypofractionated radiation are not eligible.
• No active rash or pre-existing dermatitis within the treatment field.
• No co-existing medical conditions resulting in life expectancy < 2 years.
• No active collagen vascular diseases (i.e. lupus erythematosus, scleroderma, dermatomyositis).
• No concomitant cytotoxic chemotherapy. Endocrine therapy and HER2 directed therapies are allowed.
• No current inflammatory breast cancer, or gross dermal involvement at initiation of radiotherapy.
• No previous history of organ or bone marrow transplant.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• In order to complete the mandatory patient-completed measures, participants must be able to speak and read English.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

Arm I (standard of care)

Active Comparator group

Description:

Patients receive standard of care skin management during radiation therapy for up to 6 weeks.

Treatment:

Other: Questionnaire Administration

Other: Best Practice

Other: Quality-of-Life Assessment

Arm II (Mepitel Film)

Experimental group

Description:

Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.

Treatment:

Device: Wound Dressing Material

Other: Questionnaire Administration

Other: Quality-of-Life Assessment