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

NCT03990597 | Withdrawn Phase 1 FDA Device

• 2 other identifiers: 2018-0980NCI-2019-02709
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Sarcoma; Ependymoma; Glioma; Malignant Intracranial Germ Cell Tumor; Medulloblastoma; Pineoblastoma; Primary Central Nervous System Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

• StrataXRT as a preventative agent for radiation-associated dermatitis

  To estimate the efficacy of StrataXRT among pediatric patients.

  Up to 6 weeks

Secondary Outcomes (3)

• Dosing of StrataXRT

  Up to 6 weeks

• Parent-reported symptom experience

  Up to 6 weeks

• Compliance

  Up to 6 weeks

Study Arms (1)

Supportive care (StrataXRT, placebo)

EXPERIMENTAL

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

Interventions

Placebo Administration OTHER

Applied topically

Also known as: placebo, placebo therapy, PLCB, sham therapy

Supportive care (StrataXRT, placebo)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (StrataXRT, placebo)

Wound Dressing Material DRUG

Applied StrataXRT topically

Also known as: Wound Dressing

Supportive care (StrataXRT, placebo)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Ependymoma; Glioma; Medulloblastoma; Pinealoma; Central Nervous System Neoplasms

Interventions

Bandages

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Brain Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Susan L McGovern

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: August 19, 2019
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: October 9, 2024

Record last verified: 2020-11

Locations

US (1)