CompletedNot Applicable

Determining Molecular Drivers of Radiation Dermatitis

United States20 participantsStarted 2021-02-21

Plain-language 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).

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in skin

Timeframe: Baseline, final week of radiation

Trial details

NCT IDNCT04764682

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-16

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