StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03990597

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

15.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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

Detailed Description

PRIMARY OBJECTIVES:

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.
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:

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).
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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 :

Aug 19, 2019

Actual Primary Completion Date :

Nov 24, 2020

Actual Study Completion Date :

Nov 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 Applied topically Other Names: placebo placebo therapy PLCB sham therapy Other: Questionnaire Administration Ancillary studies Drug: Wound Dressing Material Applied StrataXRT topically Other Names: Wound Dressing

Arm

Intervention/Treatment

Experimental: Supportive care (StrataXRT, placebo)

Other: Placebo Administration

Applied topically

Other Names:

placebo

placebo therapy

PLCB

sham therapy

Other: Questionnaire Administration

Ancillary studies

Drug: Wound Dressing Material

Applied StrataXRT topically

Other Names:

Wound Dressing

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [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 [Up to 6 weeks]
To estimate the efficacy of StrataXRT among pediatric patients.

Secondary Outcome Measures

Dosing of StrataXRT [Up to 6 weeks]
Parent-reported symptom experience [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 [Up to 6 weeks]
As documented in a study log by participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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