Status:
UNKNOWN
Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
Lead Sponsor:
China Medical University Hospital
Conditions:
Breast Cancer
Radiation Dermatitis
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Breast cancer is the top one incidence of cancer in women. Whole breast radiation therapy plays an indispensable role in the course of breast cancer treatment, and the radiation dermatitis is the majo...
Eligibility Criteria
Inclusion
- Participants must be males or non-pregnant females at least 20 years of age.
- Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment.
- Patients were scheduled to receive 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 or hypofraction irradiation fraction(with 2.66 Gy per session) for total dose of at least 42.56 Gy.
- Participant must give informed consent.
Exclusion
- Bilateral breast cancer
- Previous radiotherapy to the chest
- Chemotherapy concurrent with radiation treatment
- 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 :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06040983
Start Date
September 18 2023
End Date
December 31 2024
Last Update
September 18 2023
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