Feasibility in the Prophylaxis of Radiation Dermatitis Severity

Study Overview
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Brief Summary
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To compare radiation dermatitis severity in irradiated skin protected by an agent verses uncovered skin based on photographs and track patient reported outcomes with use of the agent.

Official Title
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Evaluation of Feasibility in the Prophylaxis of Radiation Dermatitis Severity in Cancer Patients

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Drug: StrataXRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18years Undergoing external beam radiotherapy for head/neck cancer at Mayo Clinic Rochester campus. Note: patients undergoing concurrent chemotherapy are eligible. Able to provide informed written consent Willing to consent for photography of radiation field Receiving a dose ≥ 45 Gy and 20 fractions to both the area being treated and the area being used for comparison Exclusion Criteria: Patients with active rash, pre-existing dermatitis, lupus, tattoos, scleroderma or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion. Patients with known allergic and other systemic skin diseases even if not directly affecting irradiated fields. Any medical condition that in the opinion of the investigator should exclude him/her from participating in the study. Enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1- StrataXRT<br> | Drug: StrataXRT<br>* Patients will be asked to start topical application of their allocated topical preparation on the area of skin that will be irradiated at the onset of radiation therapy, every day until skin symptoms subside (see patient information pamphlet). Apply twice per day and can be reapplied as skin symptoms arise or as needed. The amount of StrataXRT provided to each patient will be recorded throughout treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs. |  | First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes | Patients will be asked to complete a survey at the end of study that will ask them to provide feedback on the agent used during their treatment. | Upon study completion, on average 6 weeks, but will vary per patient |