Breast Cancer Clinical Trial

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

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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

216

Study ID:

NCT04989504

Recruitment Status:

Recruiting

Sponsor:

Alliance for Clinical Trials in Oncology

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 10 Locations for this study

See Locations Near You

Beebe South Coastal Health Campus
Frankford Delaware, 19945, United States More Info
Site Public Contact
Contact
302-645-3100
[email protected]
Gregory A. Masters
Principal Investigator
Helen F Graham Cancer Center
Newark Delaware, 19713, United States More Info
Site Public Contact
Contact
302-623-4450
[email protected]
Gregory A. Masters
Principal Investigator
Medical Oncology Hematology Consultants PA
Newark Delaware, 19713, United States More Info
Site Public Contact
Contact
302-623-4450
[email protected]
Gregory A. Masters
Principal Investigator
Beebe Health Campus
Rehoboth Beach Delaware, 19971, United States More Info
Site Public Contact
Contact
302-645-3100
[email protected]
Gregory A. Masters
Principal Investigator
Mercy Cancer Center-West Lakes
Clive Iowa, 50325, United States More Info
Site Public Contact
Contact
515-358-6613
[email protected]
Richard L. Deming
Principal Investigator
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States More Info
Site Public Contact
Contact
515-358-6613
[email protected]
Richard L. Deming
Principal Investigator
Mercy Hospital Springfield
Springfield Missouri, 65804, United States More Info
Site Public Contact
Contact
417-269-4520
Jay W. Carlson
Principal Investigator
Glens Falls Hospital
Glens Falls New York, 12801, United States More Info
Site Public Contact
Contact
518-926-6700
Timothy M. Zagar
Principal Investigator
Altru Cancer Center
Grand Forks North Dakota, 58201, United States More Info
Site Public Contact
Contact
701-780-6520
Grant R. Seeger
Principal Investigator
Saint Francis Hospital
Greenville South Carolina, 29601, United States More Info
Site Public Contact
Contact
864-603-6213
[email protected]
Jennifer Vogel
Principal Investigator
Saint Francis Cancer Center
Greenville South Carolina, 29607, United States More Info
Site Public Contact
Contact
864-603-6213
[email protected]
Jennifer Vogel
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

216

Study ID:

NCT04989504

Recruitment Status:

Recruiting

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.