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

Phase 1

Withdrawn

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

Interventions: Other: Placebo Administration
Other: Questionnaire Administration
Drug: Wound Dressing Material

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Supportive care (StrataXRT, placebo)	Wound Dressing Material	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.
Supportive care (StrataXRT, placebo)	Placebo Administration	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.
Supportive care (StrataXRT, placebo)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 6 weeks	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.
StrataXRT as a preventative agent for radiation-associated dermatitis	Up to 6 weeks	To estimate the efficacy of StrataXRT among pediatric patients.

Secondary Outcome Measures

Name	Time	Method
Compliance	Up to 6 weeks	As documented in a study log by participants.
Dosing of StrataXRT	Up to 6 weeks
Parent-reported symptom experience	Up to 6 weeks	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 \[last day of radiation therapy\]).