Clinical trial · Interventional
Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exercise Intervention
- description
- Clinic and at home exercise sessions.
- interventionNames
- Behavioral: Exercise
Primary outcomes (2)
- measure
- Number of Participants With Greater Than 50% Compliance to Exercise Regimen
- timeFrame
- 8 weeks
- description
- Subjects will complete greater than 50% of exercise sessions during 8 week intervention. Subject report satisfaction with the intervention via questionnaires.
- measure
- Acceptability - Parent Satisfaction Survey
- timeFrame
- 8 weeks
- description
- Parents will also be asked to complete a satisfaction survey regarding the exercise program, DVDs, and therapist support. The satisfaction survey consists of 13 items. Scores were on a Likert scale 1-5, 1 - strongly disagree and 5 - strongly agree. The total range is 13-65 with 65 being the greatest satisfaction possible and 13 being the worst satisfaction possible.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants will be eligible for this study if they are: 1. age ≥ 5 and ≤ 18 years, 2. have been diagnosed with acute lymphoblastic leukemia (ALL), 3. will undergo the standard of care treatment for ALL with vincristine. 4. will have a TNS-PV score of \>3 at week 6 Exclusion Criteria: * Participants will be ineligible for this study if they have: 1. baseline peripheral neuropathy greater than grade 1 (prior to receiving any doses of vincristine), 2. evidence of significant liver dysfunction, 3. Down's Syndrome, 4. pregnancy, 5. severe illness or infection, 6. current active treatment with erythropoietin, 7. administration of vitamin supplements above 100% of the recommended daily allowance
References
Publications (0)
Data not yet available