Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06865131
NA

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

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. 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-02-14

Completion Date

2025-07-03

Last Updated

2025-05-21

Healthy Volunteers

Yes

Interventions

DEVICE

StrataXRT

StrataXRT being a silicone-based cream forming a film, it is very flexible and can be applied easily to the prone position and to the contours of the large breast unlike some other barrier film skin interventions

Locations (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada