KeraStat Skin Therapy in Treating Radiation Dermatitis in Patients With Newly Diagnosed Stage 0-IIIA Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02168179|
Recruitment Status : Withdrawn (No longer pursuing study at our site.)
First Posted : June 20, 2014
Last Update Posted : July 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ductal Breast Carcinoma in Situ Skin Reactions Secondary to Radiation Therapy Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer||Procedure: dermatologic complications management/prevention Other: questionnaire administration||Not Applicable|
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.
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.
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Safety of Treatment With KeraStat Skin Therapy in Breast Cancer Patients Developing Radiation Dermatitis|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Supportive Care (KeraStat Skin Therapy)
Patients apply KeraStat Skin Therapy topically BID during radiation therapy.
Procedure: dermatologic complications management/prevention
Apply KeraStat Skin Therapy topically
Other: questionnaire administration
- 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 [ Time Frame: Up to 2 months after completion of radiation therapy ]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.
- Categorical confounders, such as race/ethnicity, age, hormone therapy, smoking history/status, diabetes, high blood pressure, breast size, RT characteristics, and RT dosimetry characteristics, using the Baseline Study Risk Questionnaire [ Time Frame: Baseline ]A series of 2xr tables will be examined to determine the relationship between each of the categorical confounders and the primary endpoint. Chi-squared statistics will be estimated for each of these tables to give some preliminary descriptive data to identify potential variables that may be associated with the primary outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168179
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Arthur Blackstock||Wake Forest University Health Sciences|