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 Withdrawn at 1 site in United States.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.
224 studies on the registry are indexed under Ependymoma; 35 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2019 to primary completion in Nov 2020, 15 months.
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This study is withdrawn, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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