Clinical trial NCT03430674: Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients
Official title: Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Greater Than 50% Compliance to Exercise Regimen
timeFrame: 8 weeks
measure: Acceptability - Parent Satisfaction Survey
timeFrame: 8 weeks
Secondary outcomes:
measure: Acceptability - Patient Satisfaction Survey
timeFrame: 8 weeks
measure: Pediatric Neuropathy
timeFrame: 8 weeks
measure: Quality of Life - Changes in Quality of Life From Pre Intervention to Post Intervention a Total of 8 Weeks.
timeFrame: Baseline and 8 weeks
measure: PDGF-BB Levels (Platelet Derived Growth Factor)
timeFrame: Baseline (T1=week 6) and T2=week 14
measure: NGF (Nerve Growth Factor)
timeFrame: Baseline (T1=week 6) and T2=week 14
measure: Quality of Life as a Result in Changes in Neuropathy Scores.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children - Indiana University
state: Indiana
Study officials:
affiliation: Riley Hospital for Children - Indiana University
name: Jamie Renbarger, MD
role: PRINCIPAL_INVESTIGATOR
References: