This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy may be a better treatment for radiation dermatitis.
PRIMARY OBJECTIVES: I. To obtain a preliminary estimate the incidence of early adverse skin reaction (EASR) during radiation therapy (RT) and up to two months post RT after the application of the cosmetic cream KeraStat Skin Therapy during RT in breast cancer patients in a pilot study. SECONDARY OBJECTIVES: I. To associate personal characteristics (e.g., race/ethnicity, age, hormone therapy, smoking status, comorbidities, breast size) and treatment characteristics (e.g., RT dose) to incidence of EASR at any time point. OUTLINE: Patients apply KeraStat Skin Therapy topically twice daily (BID) during radiation therapy. After completion of study treatment, patients are followed up at 1 and 2 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Apply KeraStat Skin Therapy topically
Ancillary studies
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Occurrence of any RT-induced EASR defined as a grade 4 or higher toxicity using the Modified Oncology Nursing Society Criteria for Radiation-Induced Acute Skin Toxicity
At each time point the proportion of women who have RT-induced EASR present will be estimated and a 95% confidence interval will be calculated around this estimate.
Time frame: Up to 2 months after completion of radiation therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.