Spots Global Cancer Trial Database for Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy
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Trial Identification
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
Study ID: NCT04989504
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fremont - Rideout Cancer Center, Marysville, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee, California, United States
Beebe South Coastal Health Campus, Frankford, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
John Fitzgerald Kennedy Medical Center, Atlantis, Florida, 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
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
MaineHealth Coastal Cancer Treatment Center, Bath, Maine, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
MaineHealth Cancer Care Center of York County, Sanford, Maine, United States
Maine Medical Center- Scarborough Campus, Scarborough, Maine, United States
Anne Arundel Medical Center, Annapolis, Maryland, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Central Maryland Radiation Oncology in Howard County, Columbia, Maryland, United States
UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie, Maryland, United States
UM Saint Joseph Medical Center, Towson, Maryland, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Saint Joseph Mercy Brighton, Brighton, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Glens Falls Hospital, Glens Falls, New York, United States
Dickstein Cancer Treatment Center, White Plains, New York, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
Holy Redeemer Hospital and Medical Center, Meadowbrook, Pennsylvania, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Tidelands Georgetown Memorial Hospital, Georgetown, South Carolina, United States
Saint Francis Hospital, Greenville, South Carolina, United States
Saint Francis Cancer Center, Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina, United States
MUSC Health Tidelands Health Radiation Therapy Center, Murrells Inlet, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
Doctor's Hospital of Laredo, Laredo, Texas, United States
University of Utah Sugarhouse Health Center, Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States
Aspirus Regional Cancer Center, Wausau, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids, Wisconsin, United States
Contact Details
Name: Kimberly Corbin, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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