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

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.

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