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Determining Molecular Drivers of Radiation Dermatitis

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Mayo Clinic

Status

Active, not recruiting

Conditions

Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04764682
19-005445

Details and patient eligibility

About

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).

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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