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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03990597
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Central Nervous System Sarcoma Ependymoma Glioma Malignant Intracranial Germ Cell Tumor Medulloblastoma Pineoblastoma Primary Central Nervous System Neoplasm Other: Placebo Administration Other: Questionnaire Administration Drug: Wound Dressing Material Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020


Arm Intervention/treatment
Experimental: Supportive care (StrataXRT, placebo)
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
Applied topically
Other Names:
  • placebo
  • placebo therapy
  • PLCB
  • sham therapy

Other: Questionnaire Administration
Ancillary studies

Drug: Wound Dressing Material
Applied StrataXRT topically
Other Name: Wound Dressing




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 6 weeks ]
    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.

  2. StrataXRT as a preventative agent for radiation-associated dermatitis [ Time Frame: Up to 6 weeks ]
    To estimate the efficacy of StrataXRT among pediatric patients.


Secondary Outcome Measures :
  1. Dosing of StrataXRT [ Time Frame: Up to 6 weeks ]
  2. Parent-reported symptom experience [ Time Frame: Up to 6 weeks ]
    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]).

  3. Compliance [ Time Frame: Up to 6 weeks ]
    As documented in a study log by participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990597


Contacts
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Contact: Susan L McGovern 713-563-2300 slmcgove@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Susan L. McGovern    713-563-2300      
Principal Investigator: Susan L. McGovern         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Susan L McGovern M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03990597    
Other Study ID Numbers: 2018-0980
NCI-2019-02709 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0980 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Ependymoma
Medulloblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Pinealoma
Dermatitis
Radiodermatitis
Neoplasms by Histologic Type
Neoplasms
Skin Diseases
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive
Radiation Injuries
Wounds and Injuries
Neoplasms by Site
Nervous System Diseases
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases