Glioma Clinical Trial
Official title:
A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy
Verified date | November 2020 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 24, 2020 |
Est. primary completion date | November 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 17 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 6 weeks | |
Primary | StrataXRT as a preventative agent for radiation-associated dermatitis | To estimate the efficacy of StrataXRT among pediatric patients. | Up to 6 weeks | |
Secondary | Dosing of StrataXRT | Up to 6 weeks | ||
Secondary | 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]). | Up to 6 weeks | |
Secondary | Compliance | As documented in a study log by participants. | Up to 6 weeks |
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