Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

February 11, 2020 updated by: Wake Forest University Health Sciences

Pilot Study: KeraStat Cream for Radiation Dermatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+)
  • Area to be irradiated representing 1-10% of total body surface area (TBSA)
  • Able and willing to sign protocol consent form
  • Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
  • Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria:

  • Women who are pregnant, lactating/nursing or plan to become pregnant
  • Previous radiation therapy to the area to be treated with radiation therapy
  • Receiving palliative radiation therapy
  • Unhealed or infected surgical sites in the irradiation area
  • Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
  • Use of oral corticosteroids or topical corticosteroids in the irradiation area
  • Use of Erbitux
  • Autoimmune disease
  • Skin disease in target irradiation area
  • Smoker
  • Known allergy to the standard of care or ingredients in KeraStat Cream

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group I (topical keratin)
Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Device: Topical Keratin
Given topically
Other Names:
  • KeraStat
ACTIVE_COMPARATOR: Group II (standard of care)
Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Early Adverse Skin Reactions (EASRs)
Time Frame: Up to 4 weeks post-RT
The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.
Up to 4 weeks post-RT
Change in Quality of Life
Time Frame: Baseline to up to 7 weeks
A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
Baseline to up to 7 weeks
Physician Observed Improvement in Skin Appearance
Time Frame: Baseline to up to 7 weeks
Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
Baseline to up to 7 weeks
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Time Frame: Baseline to up to 7 weeks
Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score.
Baseline to up to 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Karen Winkfield, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 26, 2018

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

November 1, 2018

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (ACTUAL)

December 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00046759
  • P30CA012197 (U.S. NIH Grant/Contract)
  • NCI-2017-02011 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • CCCWFU 97417 (OTHER: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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