ClinConnect ClinConnect Logo
Search / Trial NCT06915857

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

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Apr 4, 2025

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Topical Betamethasone Prone Position

ClinConnect Summary

This clinical trial is studying the effects of a topical cream called betamethasone in preventing skin problems caused by radiation therapy in large-breasted patients with breast cancer. Radiation therapy can lead to skin issues known as radiation dermatitis, which can be uncomfortable and affect a patient’s quality of life. The trial aims to compare the effectiveness of betamethasone cream to standard skin care treatments in reducing the severity of these skin issues for patients treated in a specific position called the prone position.

To participate in this trial, patients must be women aged 18 or older with a confirmed diagnosis of breast cancer and a bra size of 40 or larger/D cup. They should be scheduled to receive radiation therapy in the prone position. Participants will receive either the betamethasone cream or standard care during their treatment and for two weeks afterward. Throughout the trial, patients will have regular check-ins to assess their skin reactions and overall well-being. This study is important because it hopes to find a cost-effective and practical way to help large-breasted patients manage skin problems during radiation therapy.

Gender

ALL

Eligibility 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.

About Sunnybrook Health Sciences Centre

Sunnybrook Health Sciences Centre is a leading academic health science organization located in Toronto, Canada, renowned for its commitment to advancing patient care through innovative research and education. As a prominent clinical trial sponsor, Sunnybrook integrates cutting-edge medical research with clinical practice, focusing on a wide range of health disciplines, including cancer care, trauma, and cardiovascular health. The center collaborates with various stakeholders, including academic institutions, healthcare providers, and industry partners, to facilitate the development of novel therapies and improve health outcomes. With a robust infrastructure and a dedicated team of researchers and clinicians, Sunnybrook plays a pivotal role in translating scientific advancements into tangible benefits for patients.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Edward LW Chow, MBBS

Principal Investigator

Sunnybrook Health Sciences Centre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported