Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study: KeraStat Cream for Radiation Dermatitis

Conditions
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Breast Carcinoma, Radiation-Induced Dermatitis

Intervention / Treatment
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* Other: Best Practice
* Other: Quality-of-Life Assessment
* Device: Topical Keratin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (topical keratin)<br>Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks). | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Device: Topical Keratin<br>* Given topically<br>* Other names: KeraStat;|
| Active Comparator: Group II (standard of care)<br>Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 4 weeks post-RT | 
| 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. | Baseline to up to 7 weeks | 
| 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. | Baseline to up to 7 weeks | 
| 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. | Baseline to up to 7 weeks |