StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord
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|ClinicalTrials.gov Identifier: NCT03990597|
Recruitment Status : Withdrawn (Per PI)
First Posted : June 19, 2019
Last Update Posted : December 1, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Sarcoma Ependymoma Glioma Malignant Intracranial Germ Cell Tumor Medulloblastoma Pineoblastoma Primary Central Nervous System Neoplasm||Other: Placebo Administration Other: Questionnaire Administration Drug: Wound Dressing Material||Phase 1|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy|
|Actual Study Start Date :||August 19, 2019|
|Actual Primary Completion Date :||November 24, 2020|
|Actual Study Completion Date :||November 24, 2020|
Experimental: Supportive care (StrataXRT, placebo)
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 StrataXRT topically
Other Name: Wound Dressing
- Incidence of adverse events [ Time Frame: 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 [ Time Frame: Up to 6 weeks ]To estimate the efficacy of StrataXRT among pediatric patients.
- Dosing of StrataXRT [ Time Frame: Up to 6 weeks ]
- Parent-reported symptom experience [ Time Frame: 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 [ Time Frame: Up to 6 weeks ]As documented in a study log by participants.
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|Ages Eligible for Study:||2 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990597
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Susan L McGovern||M.D. Anderson Cancer Center|
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2019-02709 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0980 ( Other Identifier: M D Anderson Cancer Center )
|First Posted:||June 19, 2019 Key Record Dates|
|Last Update Posted:||December 1, 2020|
|Last Verified:||November 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive
Wounds and Injuries
Neoplasms by Site
Nervous System Diseases
Central Nervous System Diseases