Comparing Betamethasone and Moisturizer for Skin Care in Breast Cancer Patients
Official title: A Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Prone Position: A Randomized Phase III Trial
Run by Sunnybrook Health Sciences Centre · NCT06915857 · Data updated 2026-11-12
This study is testing whether a skin cream called betamethasone can help prevent skin problems from radiation therapy in large-breasted breast cancer patients compared to using just a moisturizer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 276 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | February 26, 2025 |
| Main results expected | September 6, 2026 |
| Study ends | December 6, 2026 |
| Registry record updated | May 21, 2025 |
| Trial ID | NCT06915857 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are female patients aged 18 and older with large breast sizes who are scheduled to receive radiotherapy after breast-conserving surgery.
✕Probably not a fit
Patients who have active dermatitis in the treatment area or those receiving concurrent cytotoxic chemotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of topical betamethasone compared to a moisturizer in preventing radiation dermatitis in large-breasted patients undergoing radiotherapy in the prone position. Radiation dermatitis is a common side effect of breast cancer treatment that can significantly affect patients' quality of life. The study aims to determine if betamethasone can further reduce the incidence of skin toxicity beyond the benefits already observed with the prone treatment position. Participants will be randomized to receive either treatment while undergoing radiation therapy, and their skin reactions will be monitored throughout the process.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of radiation dermatitis in high-risk breast cancer patients, improving their quality of life during treatment.
How similar studies have gone: Previous studies have shown that positioning patients in the prone position during radiotherapy can reduce the incidence of skin toxicity, indicating that this approach has been effective in similar contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Edward LW Chow, MBBS — Sunnybrook Health Sciences Centre
- Study coordinator: Edward LW Chow, MBBS
- Email: edward.chow@sunnybrook.ca
- Phone: 416-480-4974
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.