Status:
RECRUITING
Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Prone Position
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Breast Cancer
Radiation Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Radiotherapy (RT) is common in the treatment of breast cancer, however, 95% of breast cancer patients are at risk of developing acute and chronic skin toxicities known as radiation dermatitis (RD) whi...
Detailed Description
Breast cancer is the most common female cancer in Canada. Breast cancer patients treated with a lumpectomy require adjuvant radiotherapy (RT) to achieve local control. Radiation dermatitis (RD) is a c...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Female.
- Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes.
- Patients with large breasts \[bra size 40 in and/or D cup or greater\] and have undergone breast-conserving surgery.
- Patients are scheduled to receive conventionally- (50Gy/25#), hypo-fractionated (40Gy/15#), or extreme hypo-fractionated (26Gy/5#) photon-based radiation to whole or partial breast in prone position.
- Patients treated with or without the addition of a boost.
- Patient speaks English or can be aided by a translator.
Exclusion
- Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation.
- Prior RT to any portion of the planned treatment site.
- Active rash or pre-existing dermatitis within the treatment field.
- Concomitant cytotoxic chemotherapy.
- Unable to tolerate RT in prone.
- Treatment involves use of tissue equivalent bolus.
- Known sensitivity or allergy to betamethasone.
- Known pregnancy.
Key Trial Info
Start Date :
February 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 6 2026
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT06915857
Start Date
February 26 2025
End Date
December 6 2026
Last Update
May 21 2025
Active Locations (1)
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1
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5