Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy
NCT ID: NCT04989504
Last Updated: 2025-04-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
216 participants
INTERVENTIONAL
2022-07-26
2029-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Patient Reported Outcomes Using Mepitel Film During Radiotherapy
NCT06133218
Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Breast Cancer Patients
NCT04166799
Efficacy Study of Mepitel Film the Prophylaxis of Radiation-Induced Skin Reactions in Breast Cancer Patients
NCT03910595
Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer
NCT04149522
Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy
NCT02741258
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (standard of care)
Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
Best Practice
Receive standard of care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (Mepitel Film)
Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.
Wound Dressing Material
Apply Mepitel Film
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Best Practice
Receive standard of care
Wound Dressing Material
Apply Mepitel Film
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kimberly Corbin, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 Springfield
Springfield, Missouri, United States
Mercy Hospital Saint Louis
St Louis, 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
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2019-04688
Identifier Type: REGISTRY
Identifier Source: secondary_id
A221803
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.