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 side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in patients with breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT03374995.
See trial information on ClinicalTrials.gov for a list of participating sites.
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 radiation therapy (RT) skin toxicity as well as patients’ satisfaction with their skin after the application of the medical device topical keratin (KeraStat Cream) during RT in breast cancer patients.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive topical keratin topically at least twice daily (BID) until the end of radiation therapy (approximately 3-6 weeks).
GROUP II: Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).
After completion of study treatment, patients are followed up at 4-6 weeks.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorKaren Marie Winkfield
