Determining Molecular Drivers of Radiation Dermatitis
Active, not recruiting
- Conditions
- Breast Cancer
- Registration Number
- NCT04764682
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This study is being conducted to address key gaps in current knowledge and set the stage for rational design of strategies to prevent (pre-exposure to radiation), mitigate (post-exposure to radiation before overt signs/symptoms appear), and/or treat (post-onset of signs/symptoms) radiation dermatitis (itchy, dry skin or a rash on swollen, reddened skin).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
- Patients receiving standard-of-care postoperative radiation therapy (2-2.7 Gy per fraction) to the breast and/or chest wall for breast cancer treatment.
- Tissue diagnosis of breast cancer.
- Age > 18 years
- Signed informed consent.
- Complete blood count within normal limits within the preceding 2 weeks.
Exclusion criteria:
- Induction chemotherapy or biologic therapy
- Concurrent chemotherapy or biologic therapy
- Autoimmune disease with skin manifestations - psoriasis, dermatomyositis, scleroderma, eczema, polymyositis
- Allergy to lidocaine anesthesia
- Known bleeding diathesis (anticoagulation with warfarin, coagulation/bleeding disorders, vitamin C or K deficiency, thrombocytopenia)
- History of keloids or easy scarring
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in skin Baseline, final week of radiation A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Jacksonville, Florida, United States