Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy
- Conditions
- Breast CarcinomaMastectomy Patient
- Interventions
- Other: Best PracticeDevice: Wound Dressing MaterialOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- Registration Number
- NCT04989504
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 216
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (standard of care) Questionnaire Administration Patients receive standard of care skin management during radiation therapy for up to 6 weeks. Arm II (Mepitel Film) Questionnaire Administration Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks. Arm I (standard of care) Quality-of-Life Assessment Patients receive standard of care skin management during radiation therapy for up to 6 weeks. Arm II (Mepitel Film) Quality-of-Life Assessment Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks. Arm I (standard of care) Best Practice Patients receive standard of care skin management during radiation therapy for up to 6 weeks. Arm II (Mepitel Film) Wound Dressing Material Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.
- Primary Outcome Measures
Name Time Method Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores 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.
- Secondary Outcome Measures
Name Time Method 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 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 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 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.
Trial Locations
- Locations (49)
Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
Saint Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
Maine Medical Center- Scarborough Campus
🇺🇸Scarborough, Maine, United States
Central Maryland Radiation Oncology in Howard County
🇺🇸Columbia, Maryland, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
AnMed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
Tidelands Georgetown Memorial Hospital
🇺🇸Georgetown, South Carolina, United States
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
ThedaCare Regional Cancer Center
🇺🇸Appleton, Wisconsin, United States
Fremont - Rideout Cancer Center
🇺🇸Marysville, California, United States
McFarland Clinic - Ames
🇺🇸Ames, Iowa, United States
Mercy Hospital
🇺🇸Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Mercy Cancer Center-West Lakes
🇺🇸Clive, Iowa, United States
Delbert Day Cancer Institute at PCRMC
🇺🇸Rolla, Missouri, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
Glens Falls Hospital
🇺🇸Glens Falls, New York, United States
Dickstein Cancer Treatment Center
🇺🇸White Plains, New York, United States
Holy Redeemer Hospital and Medical Center
🇺🇸Meadowbrook, Pennsylvania, United States
Doctor's Hospital of Laredo
🇺🇸Laredo, Texas, United States
University of Utah Sugarhouse Health Center
🇺🇸Salt Lake City, Utah, United States
Altru Cancer Center
🇺🇸Grand Forks, North Dakota, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Medical Oncology Hematology Consultants PA
🇺🇸Newark, Delaware, United States
Maine Medical Center-Bramhall Campus
🇺🇸Portland, Maine, United States
University of Maryland/Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
MaineHealth Cancer Care Center of York County
🇺🇸Sanford, Maine, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
MUSC Health Tidelands Health Radiation Therapy Center
🇺🇸Murrells Inlet, South Carolina, United States
Aspirus Cancer Care - Wisconsin Rapids
🇺🇸Wisconsin Rapids, Wisconsin, United States
Aspirus Regional Cancer Center
🇺🇸Wausau, Wisconsin, United States
Saint Joseph Mercy Brighton
🇺🇸Brighton, Michigan, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Gibbs Cancer Center-Pelham
🇺🇸Greer, South Carolina, United States
Beebe South Coastal Health Campus
🇺🇸Frankford, Delaware, United States
Saint Francis Hospital
🇺🇸Greenville, South Carolina, United States
John Fitzgerald Kennedy Medical Center
🇺🇸Atlantis, Florida, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
UM Saint Joseph Medical Center
🇺🇸Towson, Maryland, United States
Trinity Health Saint Mary Mercy Livonia Hospital
🇺🇸Livonia, Michigan, United States
Beebe Health Campus
🇺🇸Rehoboth Beach, Delaware, United States
MaineHealth Coastal Cancer Treatment Center
🇺🇸Bath, Maine, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
🇺🇸Glen Burnie, Maryland, United States
Huntsman Cancer Institute/University of Utah
🇺🇸Salt Lake City, Utah, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
🇺🇸Des Moines, Iowa, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
🇺🇸Truckee, California, United States