Status:
COMPLETED
Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients
Lead Sponsor:
Indiana University
Conditions:
Peripheral Neuropathy
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
The purpose of this study is to better understand whether or not children with ALL can complete an exercise program during treatment and whether or not that program may impact peripheral neuropathy. R...
Detailed Description
Baseline visit (week 6): This visit may take up to 1.5 hours total. * The subject's exercise therapist will meet with them to discuss what they can expect throughout the program period. The subject ...
Eligibility Criteria
Inclusion
- Participants will be eligible for this study if they are:
- age ≥ 5 and ≤ 18 years,
- have been diagnosed with acute lymphoblastic leukemia (ALL),
- will undergo the standard of care treatment for ALL with vincristine.
- will have a TNS-PV score of \>3 at week 6
Exclusion
- Participants will be ineligible for this study if they have:
- baseline peripheral neuropathy greater than grade 1 (prior to receiving any doses of vincristine),
- evidence of significant liver dysfunction,
- Down's Syndrome,
- pregnancy,
- severe illness or infection,
- current active treatment with erythropoietin,
- administration of vitamin supplements above 100% of the recommended daily allowance
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03430674
Start Date
July 1 2018
End Date
October 30 2019
Last Update
March 27 2023
Active Locations (1)
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1
Riley Hospital for Children - Indiana University
Indianapolis, Indiana, United States, 46202