StrataXRT for Radiation Burn
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving cytotoxic chemotherapy (a type of cancer treatment that uses drugs to kill cancer cells).
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for large-breasted women with breast cancer who are receiving adjuvant radiation therapy. It's specifically looking at those using a prone technique to reduce skin reactions. Participants must meet certain health criteria, but specific inclusion and exclusion details aren't provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation Treatment
Participants receive adjuvant breast radiation treatment using a prone technique, with StrataXRT applied daily
Post-Treatment
Participants continue to apply StrataXRT for a minimum of 2 weeks post-radiation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of radiation dermatitis and quality of life
Treatment Details
Interventions
- StrataXRT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor