๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-05-16

Efficacy Study With StrataXRT for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment in Large Breasted Women Using a Prone Technique (NCT06865131)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Sunnybrook Health Sciences Centre

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Odette Cancer Centre, Sunnybrook Health Sciences Centre โ€” Toronto, Ontario

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Odette Cancer Centre, Sunnybrook Health Sciences Centre โ€” Toronto, Ontario

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Cancer clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—