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

• ClinicalTrials.gov Identifier: NCT03430674
• Recruitment Status: Completed
• First Posted: February 13, 2018
• Last Update Posted: January 27, 2020
• Sponsor: Indiana University
• Information provided by (Responsible Party): Indiana University

Study Description

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. 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.

Condition or disease	Intervention/treatment	Phase
Peripheral Neuropathy	Behavioral: Exercise	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: October 30, 2019
• Actual Study Completion Date: October 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exercise Intervention; Clinic and at home exercise sessions.	Behavioral: Exercise; Exercise, questionnaires and blood draws.

Outcome Measures

Primary Outcome Measures :

1. Feasibility and acceptability of exercise [ Time Frame: 8 weeks ]
   Subjects will complete greater than 50% of exercise sessions during 8 week intervention. Subject report satisfaction with the intervention via questionnaires.
2. Self-efficacy - SLT Exercise questionnaire [ Time Frame: 8 weeks ]
   We have adapted the original Bartholomew physical activity self-efficacy scale for children by adding two questions that are specifically neuropathy related and replaced the term exercise where physical activity had been used. The Self-efficacy questionnaire focuses on an individual's self-assessment of his or her ability to perform a particular exercise. Responses to the questions are limited to Yes/No and not applicable.
3. Outcome Expectations - SLT Exercise questionnaire [ Time Frame: 8 weeks ]
   These outcome expectation questions are related to how the children expect to feel after participating in regular exercise. It consists of 10 items.
4. Support - SLT Exercise Questionnaire [ Time Frame: 8 weeks ]
   These items assess support children receive from parents and peers to facilitate exercise. It consists of ten items.
5. Acceptability - Patient Satisfaction Survey [ Time Frame: 8 weeks ]
   Patients will provide feedback on the exercise program, DVDs, and therapist support. The satisfaction survey consists of 13 items.
6. Acceptability - Parent Satisfaction Survey [ Time Frame: 8 weeks ]
   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

Secondary Outcome Measures :

1. Pediatric Neuropathy [ Time Frame: 8 weeks ]
   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.
2. Quality of Life - Questions about daily life that might be a problem for some children. [ Time Frame: 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.
3. Germ line DNA [ Time Frame: 14 weeks ]
4. Neuropathic Pain [ Time Frame: 8 weeks ]
   Pediatric Neuropathic Pain Scale FIVE; Range is from 0 = No hurt to 5 = Hurts the worst
5. Chemerin levels [ Time Frame: 14 weeks ]
6. PDGF-BB levels (Platelet Derived Growth Factor) [ Time Frame: 14 weeks ]
7. IL-13 levels (Interleukin) [ Time Frame: 14 weeks ]
8. GAP 43 (Growth Associated Protein) [ Time Frame: 14 weeks ]
9. Synapsin [ Time Frame: 14 weeks ]
10. NGF (Nerve Growth Factor) [ Time Frame: 14 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Indiana

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Investigators

• Principal Investigator: Jamie Renbarger, MD; Riley Hospital for Children - Indiana University

More Information

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT03430674
• Other Study ID Numbers: 1708708583
• First Posted: February 13, 2018
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases