StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord

Study Overview
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Brief Summary
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This phase I trial studies the side effects of a silicone topical wound dressing (StrataXRT) and to see how well it works in preventing radiation dermatitis (skin burns and side effects caused by radiation) in pediatric patients undergoing radiation therapy. StrataXRT may help prevent or decrease severe skin rash, pain, itching, skin peeling, and dry skin in pediatric patients undergoing radiation therapy to the brain or spinal cord.

Detailed Description
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PRIMARY OBJECTIVES: I. To estimate the safety (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) of StrataXRT and placebo by assessing gel-associated toxicities among pediatric patients, aged 2-17 undergoing proton cerebrospinal irradiation (CSI) for central nervous system (CNS) tumors. II. To estimate the efficacy of StrataXRT as a preventative agent for radiation-associated dermatitis among pediatric patients, aged 2-17 undergoing proton CSI for CNS tumors. SECONDARY OBJECTIVES: I. To explore the relationship between dosing and the efficacy of StrataXRT. II. To explore the relationship between the use of StrataXRT and parent-reported symptom experience, as measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). III. To explore compliance with the application of treatment as documented in a study log by participants. OUTLINE: Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear twice daily (BID) until the last day of radiation therapy.

Official Title
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A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy

Conditions
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Central Nervous System Sarcoma, Ependymoma, Glioma, Malignant Intracranial Germ Cell Tumor, Medulloblastoma, Pineoblastoma, Primary Central Nervous System Neoplasm

Intervention / Treatment
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* Other: Placebo Administration
* Other: Questionnaire Administration
* Drug: Wound Dressing Material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients between the ages of 2 years old and 17 years old Patients diagnosed with primary CNS tumors including medulloblastoma, pineoblastoma, ependymoma, intracranial germ cell, glioma or intracranial sarcoma who will be starting proton CSI Patients planned to receive at least 20 Gy CSI at 1.8 - 2.0 Gy per fraction Patients with an identified adult (aged 18 years or older caregiver)(familial or other) who consents to apply the StrataXRT and placebo twice a day for the duration of the study and complete the study instruments Informed consent by parents or legal guardian; consent documents will be translated with non-English speaking participants Exclusion Criteria: Patients who have already started proton CSI treatment Patients receiving > 10 fractions photon therapy Patients with pre-existing dermal scarring, as determined by a clinical member of the study staff Patients who only have a primary caregiver who is a minor (e.g. mother under the age of 18) Patients planned to receive less than 20 Gy CSI at 1.8-2.0 Gy per fraction

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (StrataXRT, placebo)<br>Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear BID until the last day of radiation therapy. | Other: Placebo Administration<br>* Applied topically<br>* Other names: sham therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>Drug: Wound Dressing Material<br>* Applied StrataXRT topically<br>* Other names: Wound Dressing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be summarized with standard summary statistics by adverse event (AE), grade, relation, etc. using the CTCAE 5.0. All summaries will be calculated for each control and experimental forehead and ears. | Up to 6 weeks | 
| StrataXRT as a preventative agent for radiation-associated dermatitis | To estimate the efficacy of StrataXRT among pediatric patients. | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosing of StrataXRT |  | Up to 6 weeks | 
| Parent-reported symptom experience | Will be measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The RISRAS Radiation-Induced Skin Reaction Assessment Scale will be summarized by control and experimental ears at each time point (baseline, 5 weekly treatment visits, and at treatment completion visit [last day of radiation therapy]). | Up to 6 weeks | 
| Compliance | As documented in a study log by participants. | Up to 6 weeks |