Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer, Radiotherapy; Adverse Effect, Dermatitis or Eczema, Radiotherapy Side Effect, Radiation Burn, Radiation Dermatitis, Radiotherapy; Complications

In brief

The purpose of this research is to evaluate the use of Mepitel Film® in preventing radiation epidermitis in patients receiving radiation treatment for breast cancer. Mepitel® Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. Mepitel ® film is not made with natural rubber latex (NRL). It is FDA approved for the management of superficial wounds, such as superficial burns. As a part of this research study, the Mepitel Film® will be placed prior to participant's first radiation treatment, and will be removed one week following the end of treatment. Throughout the study, information will be collected to analyze at the end of the research study to determine if the Mepitel Film® helps prevent skin breakdown. The subjects will be followed per standard of care and examined for skin redness, warmth or swelling as normally examined and cared for during standard radiation therapy. If radiation burns are noted, the subject will be treated normally and depending on the severity of the radiation burns, may be removed from the study treatment and treated through standard of care.

Key facts

Study ID

NCT04149522

Run by

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

People needed

40

Starts

2020-01-15

Expected to finish

2023-11-06

Last updated by the study team

2023-11-08

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women 18 - 80 years of age
• Biopsy-proven diagnosis of breast cancer (Stage 0 - II) with the breast tumor completely removed
• Whole breast or chest wall irradiation with or without ipsilateral axillary radiotherapy
• Women of child-bearing potential must use an effective form of birth control

You may not qualify if…

• Women who are pregnant or lactating
• Women with evident skin irritation or skin infection (i.e. active rash, pre-existing dermatitis) or known allergy to adhesives or tapes; or known allergy to the Mepitel Film®
• Women with a chest abnormality that would preclude application of the Film;
• Women who in the investigator's opinion are not capable of completing the trial or following trial procedures

Where it is running

• AHN Cancer Institute at Jefferson Hospital — Clairton, Pennsylvania, United States
• AHN Cancer Institute Forbes — Monroeville, Pennsylvania, United States
• AHN Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• AHN West Penn Hospital — Pittsburgh, Pennsylvania, United States
• AHN Wexford Health + Wellness Pavilion — Wexford, Pennsylvania, United States

Full record on ClinicalTrials.gov

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