KeraStat Skin Therapy in Treating Radiation Dermatitis in Patients With Newly Diagnosed Stage 0-IIIA Breast Cancer

Safety of Treatment With KeraStat Skin Therapy in Breast Cancer Patients Developing Radiation Dermatitis

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.

Study Overview

• Status: Withdrawn
• Conditions: Stage IIIA Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Ductal Breast Carcinoma in Situ; Skin Reactions Secondary to Radiation Therapy
• Intervention / Treatment: Other: questionnaire administration; Procedure: dermatologic complications management/prevention

Detailed Description

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (KeraStat Skin Therapy); Patients apply KeraStat Skin Therapy topically BID during radiation therapy.	Other: questionnaire administration; Ancillary studies; Procedure: dermatologic complications management/prevention; Apply KeraStat Skin Therapy topically; Other Names: complications management/prevention, dermatologic; management/prevention, dermatologic complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 months after completion of radiation therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Wounds and Injuries; Breast Diseases; Radiation Injuries; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Carcinoma in Situ; Breast Neoplasms; Dermatitis; Breast Carcinoma In Situ; Radiodermatitis; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast
• Other Study ID Numbers: IRB00028009; P30CA012197 (U.S. NIH Grant/Contract); NCI-2014-01274 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 98114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No