Breast Cancer
Conditions
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).
Interventions
None listed
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura Vallow, MD
Mayo Clinic
Outcome results
None listed