Evaluating skin reactions in breast cancer patients undergoing radiotherapy
Quantifying Radiation-Induced Skin Reactions: Establishing the Foundation for Future Prediction Models
This study is trying to see how radiotherapy affects the skin of breast cancer patients and how it impacts their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Taichung) |
| Trial ID | NCT06029231 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on assessing the skin reactions experienced by breast cancer patients who have undergone whole-breast radiotherapy following breast-conserving surgery. A total of 30 participants will be evaluated weekly during their radiotherapy sessions and again at two specific follow-up points after treatment. The aim is to quantify the acute and chronic skin reactions, particularly radiation dermatitis, to better understand their impact on patient quality of life and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include adult males or non-pregnant females diagnosed with non-inflammatory breast adenocarcinoma or in situ breast cancer scheduled for radiotherapy after surgery.
Not a fit: Patients with bilateral breast cancer, previous chest radiotherapy, or known radiosensitivity syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction models for radiation-induced skin reactions, enhancing patient care and treatment planning.
How similar studies have performed: While there have been studies on radiation dermatitis, this specific approach to quantifying skin reactions in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be males or non-pregnant females at least 18 years of age. * Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which will be treated by radiotherapy after operation. * Patient had unilateral breast conservation surgery with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment. * Patients were scheduled to receive at least five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy. * Participant must give informed consent. Exclusion Criteria: * Bilateral breast cancer * Previous radiotherapy to the chest * Prior breast reconstructions, implants, and/or expanders * Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia) * Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE) * Participation in any clinical trial in the prior 30 days from baseline. * Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Where this trial is running
Taichung
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chin-Nan Chu
- Email: lucas0416@msn.com
- Phone: 886-4-22052121
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.