Status:
COMPLETED
Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Carcinoma
Radiation-Induced Dermatitis
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common s...
Detailed Description
PRIMARY OBJECTIVES: I. To determine a preliminary estimate of the improvement of skin's natural barrier, decrease of dehydration, and reduction in the appearance of inflammation associated with radia...
Eligibility Criteria
Inclusion
- Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+)
- Area to be irradiated representing 1-10% of total body surface area (TBSA)
- Able and willing to sign protocol consent form
- Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
- Able and willing to have photographs of the affected area taken regularly
Exclusion
- Women who are pregnant, lactating/nursing or plan to become pregnant
- Previous radiation therapy to the area to be treated with radiation therapy
- Receiving palliative radiation therapy
- Unhealed or infected surgical sites in the irradiation area
- Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
- Use of oral corticosteroids or topical corticosteroids in the irradiation area
- Use of Erbitux
- Autoimmune disease
- Skin disease in target irradiation area
- Smoker
- Known allergy to the standard of care or ingredients in KeraStat Cream
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03374995
Start Date
March 26 2018
End Date
November 1 2018
Last Update
June 11 2024
Active Locations (1)
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1
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157