Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

Study Overview
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Brief Summary
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This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck. Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.

Detailed Description
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Primary Objective(s) • To determine the feasibility of the use of KeraStat Cream in patients receiving radiotherapy for head and neck cancer. Secondary Objective(s) To determine the tolerability of KeraStat Cream in patients receiving radiotherapy for head and neck cancer compared to routine skin care. To assess the effectiveness of KeraStat Cream in reducing the severity of EASR in patients receiving radiotherapy for head and neck cancer, compared to routine skin care. This will be performed by evaluating: Objective evaluation of EASR using the CTCAE Version 5.0 scale of radiation dermatitis, Patient-reported outcomes of radiation dermatitis using the PRO-CTCAE version 1.0, and Dermatologic-specific quality of life assessment To estimate the amount of KeraStat Cream used per patient and coverage on the skin.

Official Title
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Pilot Study of KeraStat® Cream for Radiation Dermatitis During Head and Neck Radiotherapy

Conditions
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Head and Neck Cancer, Radiation Dermatitis

Intervention / Treatment
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* Device: KeraStat Cream
* Other: Routine Skin Care - Commercially Available Agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of head and neck cancer planned to receive conventionally-fractionated definitive radiotherapy to the head and neck to a total prescribed dose of at least 60 Gy Able and willing to sign protocol consent form Able and willing to complete tolerability and quality of life assessments 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 Active, medically necessary use of topical corticosteroids in the irradiation area Active scleroderma or lupus requiring systemic medication Treatment with anti-EGFR antibodies for head and neck cancer (previously or planned)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: KeraStat Skin Cream Arm<br>Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment. | Device: KeraStat Cream<br>* KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.<br>|
| Active Comparator: Routine Skin Care Arm (RSC Arm)<br>Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment. | Other: Routine Skin Care - Commercially Available Agents<br>* Commercially available skin moisturizers from an approved list that do not interfere with radiation.<br>* Other names: Petroleum based with mineral oil ointments: Aquaphor, Balmex, Elta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion Rate of Use of KeraStat Cream | Feasibility of use of KeraStat Cream is measured by participant compliance with an average of 10 or more applications per week being classified as complaint. In each arm, a 95% confidence interval will be calculated around the estimate of compliance. | Up to 1 month post treatment with radiation therapy (6-7 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Discontinuing Skin Care Regimen | Tolerability is measured by the number of patients who discontinue skin care regimen due to intolerance for any reason. In each arm, a 95% confidence interval will be calculated around the estimate of tolerability. | Up to 1 month post treatment with radiation therapy (6-7 weeks) | 
| Number of Participants With Grade 2+ Radiation Dermatitis | Objective assessment of early adverse skin reaction defined as Grade 2+ using the CTCAE version 5.0 scale of radiation dermatitis will be compared between the KeraStat group and the RSC group at the end of treatment, using a Fisher's exact test. | Up to 1 month post treatment with radiation therapy (6-7 weeks) | 
| Number of Participants Reporting Radiation Skin Reaction | Patient-reported assessment of skin toxicity using the PRO-CTCAE version 1.0 scale of radiation skin symptoms (skin dryness, itching, radiation skin reaction and skin darkening). Score scale is none to very severe and Yes or No for skin darkening. | Up to 1 month post treatment with radiation therapy | 
| Dermatology Life Quality Index Questionnaire | A 10-item questionnaire to measure how skin problems have affected participants' lives. Scoring for each question ranges from 0-3 with very much scored as 3 and not at all or not relevant score as 0. The DLQI is calculated by summing the score of each questions resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. The mean of the highest DLQI score across all time points will be compared between the KeraStat and RSC groups using a t-test. | At weeks 1-6 and up to 1 month post treatment with radiation therapy | 
| Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage | Skin coverage is defined as the total number of tubes of KeraStat Cream used over 7 weeks OVER ALL participants in the KeraStat arm only. | Up to 1 month post treatment with radiation therapy (7 weeks) |