Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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 will receive their exercise DVD to be used for at-home exercise sessions. The subject will be asked questions about how they are feeling and their general well-being. The subject will also be asked to complete several questionnaires about their neuropathy, confidence level about completing the program, support and expectations. The subject will be given a Fitbit with instructions about how and when to use it. The subject will have a sample of blood collected (15mL or about 1 tablespoon). The study team will time this blood draw to occur when they are already having blood drawn for routine clinical treatment. The subject will have a physical fitness test, which includes body measurements such as weight, height and blood pressure; also tests for physical strength, endurance and oxygen consumption. At the same time the subject is given the physical fitness test they will also be asked to not eat for 1 hour before this session. The subject will complete their first exercise session with their therapist. Weeks 6-13: During weeks 6-13 (8 weeks total), the subject will be asked to exercise for at least 15 minutes 6 times per week using the instructional DVD that was provided to them. The exercise the subject does will be tailored to their age range (either age 5-10 or 11-18) and will consist of strengthening and aerobic activities. The subject will also be asked to keep an exercise log that is provided by the study to record their exercise activity including how they felt when they exercised. The subject will be asked to perform one of their exercise sessions during weeks 8, 10, and 12 at Riley Hospital with their exercise therapist. The study team will coordinate this visit to occur during one of their regularly scheduled office visits. Post-program visit (week 14) This visit may take up to 1.5 hours total. The subject will be asked questions about how they are feeling and their general well-being. The subject will also be asked to complete several questionnaires about your neuropathy, confidence level about completing the program, support and expectations. The subject will have a sample of blood collected (15mL or about 1 tablespoon). The study team will time this blood draw to occur when they are already having blood drawn for routine clinical treatment. The subject will repeat the physical fitness test, which includes body measurements such as weight, height and blood pressure; also tests for physical strength, endurance and oxygen consumption. During the last session (week 14) the subject will also be asked to not eat for 1 hour before this session. The subject will be asked to complete a satisfaction survey.

Official Title
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Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Clinic and at home exercise sessions. | Behavioral: Exercise<br>* Exercise, questionnaires and blood draws.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Greater Than 50% Compliance to Exercise Regimen | Subjects will complete greater than 50% of exercise sessions during 8 week intervention. Subject report satisfaction with the intervention via questionnaires. | 8 weeks | 
| Acceptability - Parent Satisfaction Survey | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability - Patient Satisfaction Survey | Patients will provide feedback on the exercise program, DVDs, and therapist support. The satisfaction survey consists of 13 items. The scale is 1-5 with 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. | 8 weeks | 
| Pediatric Neuropathy | Total Neuropathy Score Pediatric Version; Range for each subscale is 0 to 4 with 0 being normal and 4 being the worst neuropathy. The total range is 0-36. 0 being no neuropathy. 36 being highest neuropathy possible. | 8 weeks | 
| Quality of Life - Changes in Quality of Life From Pre Intervention to Post Intervention a Total of 8 Weeks. | Quality of Life: Pediatric Quality of Life Inventory; Each is 0 to 4 with 0 being never and 4 being almost always. The total scale score, the mean is computed as the sum of all the items over the number of items answered on all the scales. The difference between pre and post QOL scores. Total scale score consists of 4 dimensions, physical, emotional, social, and school functioning. Scores are transformed on a scale from 0-100. The greater the score the better the quality of life. | Baseline and 8 weeks | 
| PDGF-BB Levels (Platelet Derived Growth Factor) | Changes in PDGF-BB (Platelet Derived Growth Factor) levels in plasma from pre to post intervention. | Baseline (T1=week 6) and T2=week 14 | 
| NGF (Nerve Growth Factor) | Change in NGF (Nerve Growth Factor) in plasma from pre to post intervention. | Baseline (T1=week 6) and T2=week 14 | 
| Quality of Life as a Result in Changes in Neuropathy Scores. | Analyzing the correlation of changes in quality of life scores with neuropathy scores using Pearson's correlation coefficient. | 8 weeks |