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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
NameTimeMethod
Change in skinBaseline, 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
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Jacksonville, Florida, United States

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