Clinical trial NCT03990597: StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord
Official title: A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Central Nervous System Sarcoma
Ependymoma
Glioma
Malignant Intracranial Germ Cell Tumor
Medulloblastoma
Pineoblastoma
Primary Central Nervous System Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 6 weeks
measure: StrataXRT as a preventative agent for radiation-associated dermatitis
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Dosing of StrataXRT
timeFrame: Up to 6 weeks
measure: Parent-reported symptom experience
timeFrame: Up to 6 weeks
measure: Compliance
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Susan L McGovern
role: PRINCIPAL_INVESTIGATOR
References: