KeraStat(R) Cream for Radiation Dermatitis

Study Overview
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Brief Summary
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The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.

Detailed Description
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The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial. The secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin.

Official Title
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Pilot Study: KeraStat(R) Cream for Radiation Dermatitis

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Device: KeraStat(R) Cream
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 70 Female Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more) 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 Autoimmune disease Skin disease in target irradiation area 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of care<br>Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care | Other: Standard of care<br>* Patients will be instructed to follow institutional standard of care for radiation dermatitis<br>|
| Experimental: KeraStat Cream<br>Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application. | Device: KeraStat(R) Cream<br>* KeraStat Cream is a cream wound dressing that contains 5% keratin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Therapy Oncology Group Skin Toxicity Scoring | The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point. | Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks. | 
| Dermatology Life Quality Index | The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups. | Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Evaluate safety and tolerability of application of KeraStat Cream through comparison of adverse events reported in KeraStat Cream group versus standard of care. | Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks. |