Pilot Study of Strength and Balance Training Program for Persons With Oxaliplatin Induced Neuropathy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects on strength, balance, and neuropathic symptoms (numbness, tingling, pain, weakness) of a 12 week, bi-weekly, 60 minute, group exercise program designed to improve lower extremity strength and balance with persons with oxaliplatin induced peripheral neuropathy.

Official Title
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A Pilot Study of a Strength and Balance Training Program for Persons With Oxaliplatin Induced Peripheral Neuropathy

Conditions
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Neuropathy, Gastrointestinal Cancer

Intervention / Treatment
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* Other: 12 Week Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior history of colon cancer Completed oxaliplatin based chemotherapy at least 6 months prior to enrollment Report numbness, tingling, or pain of the lower extremities ≥ 4 by chemotherapy induced peripheral neuropathy (CIPN) Visual Analog Rating Karnofsky performance status of at least 60% Able to read, write, and understand English Exclusion Criteria: Patients will be excluded from the study if they live outside of a 30 mile radius of the University of South Florida, if they are currently undergoing chemotherapy or radiation therapy, or if they regularly (at least once a week) participate in strength or balance training exercises. The investigators will not exclude participants if they are participating in aerobic exercise, but we will collect that information so that the investigators may control for aerobic exercise in our data analysis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Excercise and Questionnaire<br>12 week exercise program followed by questionnaire. | Other: 12 Week Exercise Program<br>* Participants will be asked to take part in a one hour exercise program twice a week for 12 weeks. They will also be asked to answer questionnaires and participate in an evaluation of their strength, balance, and physical function every 4 weeks immediately following the exercise program. This evaluation will take an additional hour every 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Screened Patients Who Participate and Complete the Study | To evaluate feasibility, the percentage of patients screened to percentage enrolled in the study and the percentage enrolled to percentage that completes the study will be calculated. Patients who do not complete the study will be contacted to determine why they were unable to complete the study and the reasons will be recorded. How many sessions were attended will also be recorded. | 10 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience Side Effects | To evaluate tolerability, at each session, data regarding any participant who was unable to complete the entire session will be recorded along with any side effects that participants report. Participants will also be asked to rate the level of exercise they perform at each session as either a) too easy b) just right c) too challenging. | 10 Months | 
| Number of Participants With Measured Improvement | Treatment-effect size will be evaluated by means of changes in muscle strength, balance, and neuropathy from the beginning to completion of the study. | 10 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxaliplatin Induced, Peripheral Neuropathy, Strength, Balance, Training Program, Colon, Rectal