A Phase 1 interventional study of Placebo Administration and Questionnaire Administration in Central Nervous System Sarcoma, Ependymoma and Glioma, sponsored by M.D. Anderson Cancer Center. Withdrawn at 1 site in United States. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
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 · Other: Questionnaire Administration · Drug: Wound Dressing Material
Applied topically
Also known as: placebo, placebo therapy, PLCB, sham therapy
Ancillary studies
Applied StrataXRT topically
Also known as: Wound Dressing
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.
Time frame: Up to 6 weeks
StrataXRT as a preventative agent for radiation-associated dermatitis
To estimate the efficacy of StrataXRT among pediatric patients.
Time frame: Up to 6 weeks
Dosing of StrataXRT
Time frame: 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 \[last day of radiation therapy\]).
Time frame: Up to 6 weeks
Compliance
As documented in a study log by participants.
Time frame: Up to 6 weeks
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M.D. Anderson Cancer Center