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A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients
Sponsor: Sunnybrook Health Sciences Centre
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
Conditions
Interventions
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