Efficacy Study With StrataXRT for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment in Large Breasted Women Using a Prone Technique

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. In a study published it was found that for women with large breasts (n=357), being positioned in the supine position during radiation could lower the rates of moist desquamation from 36.9% in the supine position down to 26.9% when treated in the prone position. Even though the prone position for patients with large breasts did reduce rates of moist desquamation, these results demonstrate that one in five patients still go on to develop severe reactions, even in the prone position. Building on these results, a phase II feasibility study conducted at Sunnybrook, found that the use of a silicone-based film forming topical gel known as StrataXRT could lower the incidence of moist desquamation for patients treated in the prone position even further.

NCT Number	NCT06865131
Lead Sponsor	Sunnybrook Health Sciences Centre
Conditions	Breast Cancer, Radiation Dermatitis
Enrollment	20 participants
Start Date	2024-02-14
Primary Completion	2025-07 (estimated)
Study Completion	2025-07-03 (estimated)
Updated on ClinicalTrials.gov	2025-05-21