NCT03430674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

March 27, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

November 7, 2017

Results QC Date

September 2, 2020

Last Update Submit

March 23, 2023

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Acceptability - Patient Satisfaction Survey

    8 weeks

  • Pediatric Neuropathy

    8 weeks

  • Quality of Life - Changes in Quality of Life From Pre Intervention to Post Intervention a Total of 8 Weeks.

    Baseline and 8 weeks

  • PDGF-BB Levels (Platelet Derived Growth Factor)

    Baseline (T1=week 6) and T2=week 14

  • NGF (Nerve Growth Factor)

    Baseline (T1=week 6) and T2=week 14

  • +1 more secondary outcomes

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Clinic and at home exercise sessions.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Exercise, questionnaires and blood draws.

Exercise Intervention

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Jamie Renbarger, MD
Organization
Indiana University
jarenbar@iu.edu
317-944-8784

Study Officials

  • Jamie Renbarger, MD

    Riley Hospital for Children - Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatric Cancer Research

Study Record Dates

First Submitted

November 7, 2017

First Posted

February 13, 2018

Study Start

July 1, 2018

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

March 27, 2023

Results First Posted

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)