N/A
N=10
Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients
Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT03430674 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Number of Participants With Greater Than 50% Compliance to Exercise Regimen — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise (Behavioral)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Greater Than 50% Compliance to Exercise Regimen |
— | — |
| PRIMARY Acceptability - Parent Satisfaction Survey |
4.096 | — |
| SECONDARY Acceptability - Patient Satisfaction Survey |
3.945 | — |
| SECONDARY Pediatric Neuropathy |
6 | — |
| SECONDARY Quality of Life - Changes in Quality of Life From Pre Intervention to Post Intervention a Total of 8 Weeks. |
8.17 | — |
| SECONDARY PDGF-BB Levels (Platelet Derived Growth Factor) |
66.03 | — |
| SECONDARY NGF (Nerve Growth Factor) |
37.98 | — |
| SECONDARY Quality of Life as a Result in Changes in Neuropathy Scores. |
0.80 | — |
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. Researchers will also study changes in the blood and body that may occur during the program by collecting samples of blood at various times during the study.
Aim 1: Evaluate the feasibility and acceptability of EX as an intervention for VIPN in pediatric patients with ALL.
Aim 2: Estimate preliminary effect sizes of the EX intervention.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03430674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.