Clinical Trial: NCT03430674 - My Cancer Genome

NCT03430674

Description:

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.

Related Conditions:

Acute Lymphoblastic Leukemia

Recruiting Status:

Completed

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT03430674

Trial Eligibility

Document

Title

Brief Title: 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

Clinical Trial IDs

ORG STUDY ID: 1708708583
NCT ID: NCT03430674

Conditions

Peripheral Neuropathy

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
Exercise Intervention	Experimental	Clinic and at home exercise sessions.

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

Maximum Eligible Age:	18 Years
Minimum Eligible Age:	5 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Feasibility and acceptability of exercise
Time Frame:	8 weeks
Safety Issue:
Description:	Subjects will complete greater than 50% of exercise sessions during 8 week intervention. Subject report satisfaction with the intervention via questionnaires.

Secondary Outcome Measures

Measure:	Pediatric Neuropathy
Time Frame:	8 weeks
Safety Issue:
Description:	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.

Measure:	Quality of Life - Questions about daily life that might be a problem for some children.
Time Frame:	8 weeks
Safety Issue:
Description:	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.

Measure:	Germ line DNA
Time Frame:	14 weeks
Safety Issue:
Description:

Measure:	Neuropathic Pain
Time Frame:	8 weeks
Safety Issue:
Description:	Pediatric Neuropathic Pain Scale FIVE; Range is from 0 = No hurt to 5 = Hurts the worst

Measure:	Chemerin levels
Time Frame:	14 weeks
Safety Issue:
Description:

Measure:	PDGF-BB levels (Platelet Derived Growth Factor)
Time Frame:	14 weeks
Safety Issue:
Description:

Measure:	IL-13 levels (Interleukin)
Time Frame:	14 weeks
Safety Issue:
Description:

Measure:	GAP 43 (Growth Associated Protein)
Time Frame:	14 weeks
Safety Issue:
Description:

Measure:	Synapsin
Time Frame:	14 weeks
Safety Issue:
Description:

Measure:	NGF (Nerve Growth Factor)
Time Frame:	14 weeks
Safety Issue:
Description:

Details

Phase:	N/A
Primary Purpose:	Interventional
Overall Status:	Completed
Lead Sponsor:	Indiana University

Last Updated

January 27, 2020

Clinical Trials /

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