Determining Molecular Drivers of Radiation Dermatitis

N/AActive Not RecruitingNCT04764682

Mayo Clinic20 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Change in skin

A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation.

Time frame: Baseline, final week of radiation

Data from ClinicalTrials.gov

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