Mepitel Film for Radiation Skin Damage in Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byEdward LW Chow, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin reactions which adversely impact quality of life. Importantly, patients receiving chest wall radiation or patients with large breasts are more likely to have worse skin reactions. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. In response to the lack of evidence, Sunnybrook investigators previously conducted a pilot study (REB #294-2018) of Mepitel Film and preliminary results showed improvements in high grade skin reactions. Mepitel Film has not been widely adopted in North America as more evidence is needed. The validate the efficacy of the film compared to the standard of care, a study testing the efficacy of the film is proposed. In the study, 216 patients will be randomized (2:1) to receive either the film or the institution's current skin treatments and all patients will have their skin assessed.

Eligibility Criteria

This trial is for breast cancer patients with large breasts who've had surgery and are set to receive radiation therapy. It's open to adults over 18, regardless of gender. Those with prior radiotherapy, current chemotherapy, skin conditions in the treatment area, or allergies to adhesives/silicon can't participate.

Inclusion Criteria

I have large breasts and had surgery to remove part of one breast.

My breast cancer diagnosis was confirmed through tissue examination.

I am 18 years old or older.

+4 more

Exclusion Criteria

I have a rash or skin condition in the area to be treated.

I am currently receiving chemotherapy that kills cancer cells.

You have had a reaction to adhesive, tape, or silicon in the past.

+4 more

Participant Groups

The study tests Mepitel Film against standard skin treatments for preventing radiation dermatitis in breast cancer patients receiving radiation. Of the 216 participants, two-thirds will use the film while one-third will get usual care; their skin reactions are then compared.

2Treatment groups

Experimental Treatment

Active Control

Group I: Mepitel Film ArmExperimental Treatment1 Intervention

Patients randomized to the Mepitel Film arm will receive the film for the entire duration of their radiation treatment and will be worn up to 2 weeks after completion of radiotherapy.

Group II: Standard of Care ArmActive Control1 Intervention

Patients randomized to the Standard of Care arm will be instructed to use the institutional standard of care skin treatments for the entire duration of their radiation treatment and up to 2 weeks after completion of radiotherapy.