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

M.D. Anderson Cancer Center

Status and phase

Withdrawn

Phase 1

Conditions

Pineoblastoma

Glioma

Central Nervous System Sarcoma

Medulloblastoma

Primary Central Nervous System Neoplasm

Ependymoma

Malignant Intracranial Germ Cell Tumor

Treatments

Other: Questionnaire Administration

Other: Placebo Administration

Drug: Wound Dressing Material

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03990597

NCI-2019-02709 (Registry Identifier)

2018-0980

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

2 to 17 years old

Volunteers

Accepts Healthy Volunteers

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