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Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

Primary Purpose

Breast Carcinoma, Radiation-Induced Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Quality-of-Life Assessment
Topical Keratin
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (topical keratin)

Group II (standard of care)

Arm Description

Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).

Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).

Outcomes

Primary Outcome Measures

Incidence of Early Adverse Skin Reactions (EASRs)
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.
Change in Quality of Life
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.
Physician Observed Improvement in Skin Appearance
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.
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2017
Last Updated
February 11, 2020
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03374995
Brief Title
Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer
Official Title
Pilot Study: KeraStat Cream for Radiation Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Radiation-Induced Dermatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (topical keratin)
Arm Type
Experimental
Arm Description
Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).
Arm Title
Group II (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Device
Intervention Name(s)
Topical Keratin
Other Intervention Name(s)
KeraStat
Intervention Description
Given topically
Primary Outcome Measure Information:
Title
Incidence of Early Adverse Skin Reactions (EASRs)
Description
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.
Time Frame
Up to 4 weeks post-RT
Title
Change in Quality of Life
Description
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.
Time Frame
Baseline to up to 7 weeks
Title
Physician Observed Improvement in Skin Appearance
Description
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.
Time Frame
Baseline to up to 7 weeks
Title
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Description
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.
Time Frame
Baseline to up to 7 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Winkfield
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

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