StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03990597|
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : February 26, 2020
|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)|
|Estimated Enrollment :||30 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|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 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.
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
|Contact: Susan L McGovernfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Susan L. McGovern 713-563-2300|
|Principal Investigator: Susan L. McGovern|
|Principal Investigator:||Susan L McGovern||M.D. Anderson Cancer Center|