NCT03990597

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Placebo Administration	Applied topically
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Wound Dressing Material	Applied StrataXRT topically

Timeline

• Start date: 2019-08-19
• Primary completion: 2020-11-24
• Completion: 2020-11-24
• First posted: 2019-06-19
• Last updated: 2024-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study