Clinical trial · Interventional
StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord
A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per PI
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Sarcoma | Central Nervous System Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Ependymoma | Ependymoma | ONTOLOGY_EXACT | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Malignant Intracranial Germ Cell Tumor | — | UNRESOLVED | — |
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
| Pineoblastoma | Pineoblastoma | ONTOLOGY_EXACT | 0.98 |
| Primary Central Nervous System Neoplasm | Primary Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Administration | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Wound Dressing Material | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (StrataXRT, placebo)
- description
- 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.
- interventionNames
- Other: Placebo Administration
- Other: Questionnaire Administration
- Drug: Wound Dressing Material
Primary outcomes (2)
- measure
- Incidence of adverse events
- timeFrame
- Up to 6 weeks
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available