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ACTIVE NOT RECRUITING
NCT05594498
NA

A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

Summary

For breast cancer patients undergoing adjuvant radiotherapy, radiation dermatitis (RD) is a common occurrence that can negatively impact patients' quality of life (QOL). RD often presents as erythema, pruritus, and/or edema and in more severe cases, skin breakage can occur, resulting in moist desquamation. StrataXRT is a silicone-based film-forming topical gel. Recent studies have shown the benefits of StrataXRT, but with mixed results. A recent randomized controlled trial published in 2022 found that in breast cancer patients (n=100), the use of StrataXRT significantly reduced the mean size of the radiation-induced dermatitis area (p=0.002) when compared to the control group. Additionally, another study (n=49) demonstrated significant differences in the Erythema Index (EI) (p=0.001) and Melanin Index (MI) (p=0.005) between StrataXRT compared to the use of Xderm, a moisturizer cream. To validate the finding of the previous studies a pilot study testing the efficacy of StrataXRT has been proposed. In this study, 50 patients will use Strata XRT on their breast/chest wall during radiation treatment. Their skin will be assessed throughout and post-treatment. Investigators hypothesize the severity of skin reactions will be less for patients using Strata XRT when compared to historical data from our centre.

Official title: A Pilot Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients Undergoing Adjuvant Radiotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2022-10-13

Completion Date

2025-12

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

DEVICE

StrataXRT

StrataXRT is a silicone-based film-forming topical gel that may help in reducing radiation dermatitis.

Locations (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada