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

• ClinicalTrials.gov Identifier: NCT04989504
• Recruitment Status: Active, not recruiting
• First Posted: August 4, 2021
• Last Update Posted: April 9, 2024
• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alliance for Clinical Trials in Oncology

Tracking Information

• First Submitted Date: July 26, 2021
• First Posted Date: August 4, 2021
• Last Update Posted Date: April 9, 2024
• Actual Study Start Date: July 26, 2022
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 26, 2021)

Serially measured patient-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores [ Time Frame: Up to 5 months ]

Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a patient-completed mRISRAS score ranges from 0 to 12, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 26, 2021)

• Centralized, blinded provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores obtained from a blinded grading of the photographs taken at the end of radiation therapy [ Time Frame: Up to 2 months ]
  At the completion of radiation therapy, photographs will be obtained one hour after the removal of the Mepitel Film or immediately following completion of radiation therapy for patients on the standard of care arm. A panel of radiation oncology providers will perform the blinded, central review to score the photographs. Each provider will independently assign a provider-completed mRISRAS score to each photograph, and the average score will be calculated for each patient. The provider-completed mRISRAS score ranges from 0 to 24, where higher scores correspond to increased radiation-induced skin reactions. The Wilcoxon rank-sum test will be used to test for an effect of the Mepitel Film.
• Serially measured non-blinded institutional provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores [ Time Frame: Up to 5 months ]
  Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a provider-completed mRISRAS score ranges from 0 to 24, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
• Serially measured combined patient- and provider-completed modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) scores [ Time Frame: Up to 5 months ]
  Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a provider-completed mRISRAS score ranges from 0 to 36, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy
• Official Title: Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial
• Brief Summary: 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

• Breast Carcinoma
• Mastectomy Patient

Intervention

• Other: Best Practice
  Receive standard of care
  Other Name: Standard of Care
• Device: Wound Dressing Material
  Apply Mepitel Film
• Other: Quality-of-Life Assessment
  Ancillary studies
• Other: Questionnaire Administration
  Ancillary studies

Study Arms

• Active Comparator: Arm I (standard of care)
  Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
  Interventions:

  • Other: Best Practice
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
• Experimental: Arm II (Mepitel Film)
  Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.
  Interventions:

  • Device: Wound Dressing Material
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 26, 2021): 216
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04989504
• Other Study ID Numbers: A221803; NCI-2019-04688 ( Registry Identifier: NCI Clinical Trial Reporting Program ); UG1CA189823 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Alliance for Clinical Trials in Oncology
• Original Responsible Party: Same as current
• Current Study Sponsor: Alliance for Clinical Trials in Oncology
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Kimberly Corbin, MD; Mayo Clinic

• PRS Account: Alliance for Clinical Trials in Oncology
• Verification Date: April 2024