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Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Prone Position

RecruitingPhase 3Ages 18 Years - anyAllSunnybrook Health Sciences Centre
NCT06915857 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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) which includes symptoms such as pruritus, edema, erythema, and moist desquamation (MD). Patients with a larger breast size are especially at risk of developing RD. The severity of RD can impact patient's quality of life (QOL) and their ability to complete treatment. Skin care guidelines for patients receiving RT vary and include barrier films and dressings, antibiotics, topical corticosteroids, and moisturizers. A study conducted at the Sunnybrook Odette Cancer Centre investigated the effectiveness of the prone treatment position during RT compared to the supine position. The results indicated that the prone position reduced the incidence of MD from 39.6% in supine to 26.9% in prone. However, 1

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Topical Betamethasone
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Where

1 site
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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