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

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.

• Placebo Administration (Other), also known as placebo, placebo therapy, PLCB, sham therapy: Applied topically
• Questionnaire Administration (Other): Ancillary studies
• Wound Dressing Material (Drug), also known as Wound Dressing: Applied StrataXRT topically

Primary outcomes

• 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 outcomes

• 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 \[last day of radiation therapy\]).
• Compliance [Up to 6 weeks]: As documented in a study log by participants.

Sex: All, ages: 2 Years to 17 Years, accepts healthy volunteers

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

• Informed Consent Form (PDF, 2019-07-01)

• Susan L McGovern, Principal investigator, M.D. Anderson Cancer Center