Status:
RECRUITING
Quantifying Radiation-Induced Skin Reactions: Establishing the Foundation for Future Prediction Models
Lead Sponsor:
China Medical University Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Breast cancer has the highest incidence rate among female cancers, and breast radiotherapy plays an essential role in the treatment of breast cancer. However, the acute and chronic skin reactions caus...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06029231
Start Date
October 9 2023
End Date
August 31 2024
Last Update
February 7 2024
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taiwan