Assessing skin side effects in breast cancer patients receiving radiation therapy
Prospective Assessment of Acute Skin Toxicities in Breast Cancer Patients Undergoing Retreatment with 40 Gy in 15 Fractions Radiation Therapy
This study is testing how a new radiation treatment affects the skin of breast cancer patients who are getting re-treatment to see if it causes fewer side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06729814 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on breast cancer patients who have previously undergone radiation therapy and are now receiving re-treatment with a new regimen of 40 Gy in 15 fractions. The study aims to evaluate the acute skin toxicities associated with this treatment approach, which is designed to minimize the treatment burden while effectively addressing recurrent breast cancer. By monitoring skin reactions and quality of life, the research seeks to provide valuable insights into the safety and efficacy of this radiation therapy regimen. The findings could help refine treatment protocols for patients at risk of severe radiation dermatitis.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with a history of breast cancer who have previously received radiation therapy and are scheduled for re-treatment.
Not a fit: Patients who are not receiving the specified hypofractionated radiation therapy or those with active skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that reduce skin toxicities and enhance the quality of life for breast cancer patients undergoing re-treatment.
How similar studies have performed: While there have been few studies on breast reirradiation, this specific approach of using 40 Gy in 15 fractions is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Informed consent * Histological confirmation of breast malignancy (invasive or in situ carcinoma) or phyllodes * Previous history of ipsilateral breast cancer treated with RT * Patients are planned to receive hypofractionated (40Gy/15) RT to the whole or partial breast or chest wall * Patients treated with or without the addition of a planned boost or bolus * Patients receiving local or locoregional radiation treatment * Can communicate in English or be aided by a translator Exclusion Criteria: * Patients scheduled to receive conventionally fractionated (50Gy/25 or 45Gy/25) or extreme hypofractionation (26Gy/5) * Patients planned to receive brachytherapy * Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion * Concomitant cytotoxic chemotherapy * Scleroderma
Where this trial is running
Toronto, Ontario
- Odette Cancer Center Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Irene Karam, MDCM
- Email: Irene.karam@sunnybrook.ca
- Phone: 416-480-4974
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.