Observational study on breast cancer patients receiving hypofractionated radiotherapy
Registry for Analysis of Impact of Radiation Dose to Skin on Cosmetic Outcome and Patient-reported Outcomes in Patients With Breast Cancer Treated With Radiation Therapy
This study looks at how hypofractionated radiotherapy affects breast cancer patients by checking for skin changes and cosmetic results, while also collecting feedback from patients about their experiences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05775757 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the toxicities and cosmetic outcomes in breast cancer patients who have undergone hypofractionated radiotherapy. It will assess changes in breast skin, factors influencing these changes, and gather patient-reported outcomes using various methods such as photographs, fibrometer measurements, and questionnaires (BREAST-Q). The study will evaluate these parameters before and after the radiotherapy treatment to provide a comprehensive understanding of the effects of this therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are breast cancer patients who have undergone curative surgery.
Not a fit: Patients with a history of thoracic radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of radiotherapy side effects and improve cosmetic outcomes for breast cancer patients.
How similar studies have performed: Other studies have explored similar outcomes in breast cancer radiotherapy, indicating potential for meaningful insights, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Breast cancer treated with curative surgery Exclusion Criteria: * History of thoracic radiation therapy
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Haeyoung Kim, MD, PhD — Samsung Medical Center
- Study coordinator: Haeyoung Kim, MD, PhD
- Email: haeyoung0131.kim@samsung.com
- Phone: 82-2-3410-2612
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.