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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. Identifier: NCT02168179
Recruitment Status : Withdrawn (No longer pursuing study at our site.)
First Posted : June 20, 2014
Last Update Posted : July 5, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

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

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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 Names:
  • complications management/prevention, dermatologic
  • management/prevention, dermatologic complications

Other: questionnaire administration
Ancillary studies

Primary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Newly diagnosed with breast carcinoma, stage 0-IIIA (including ductal carcinoma in situ [DCIS])
  • Status post-lumpectomy, -quadrantectomy, or -mastectomy
  • Plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes
  • Total dose >= 40Gy
  • Dose per fraction >= 1.8 use of 2-dimensional (2D), 3-dimensional (3D) conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; skin sparing IMRT patients excluded; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens
  • Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
  • Adjuvant hormonal therapy will be allowed prior to, during and/or after RT at the discretion of a medical oncologist
  • Targeted therapies such as Herceptin will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist
  • Patients who are able and willing to sign protocol consent form

Exclusion Criteria:

  • Prior radiation to the involved breast or chest wall
  • Concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion)
  • Patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed)
  • Patients undergoing partial breast irradiation
  • Patients who have undergone MammoSite® or any other form of brachytherapy
  • Patients may not be concurrently enrolled in a protocol that involves treatment of the skin ie: applying lotions /moisturizers; protocols that do not involve treatment of the skin are allowed
  • Patients who are pregnant or breastfeeding

Information from the National Library of Medicine

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 identifier (NCT number): NCT02168179

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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Principal Investigator: Arthur Blackstock Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences Identifier: NCT02168179    
Other Study ID Numbers: IRB00028009
NCI-2014-01274 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 98114
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
Radiation Injuries
Wounds and Injuries