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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03990597
• Other study ID #: 2018-0980
• Secondary ID: NCI-2019-0270920
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 19, 2019
• Est. completion date: November 24, 2020

Study information

• Verified date: November 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Sarcoma
• Dermatitis
• Ependymoma
• Glioma
• Malignant Intracranial Germ Cell Tumor
• Medulloblastoma
• Nervous System Neoplasms
• Pinealoma
• Pineoblastoma
• Primary Central Nervous System Neoplasm
• Radiodermatitis

Intervention

Other:
• Placebo Administration
Applied topically
• Questionnaire Administration
Ancillary studies

Drug:
• Wound Dressing Material
Applied StrataXRT topically

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   MD Anderson Cancer Center Website