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

NCT ID: NCT01422993

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-12-31

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.

Detailed Description

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Conditions

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Neuropathy Gastrointestinal Cancer

Keywords

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Oxaliplatin Induced Peripheral Neuropathy Strength Balance Training Program Colon Rectal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Excercise and Questionnaire

12 week exercise program followed by questionnaire.

Group Type EXPERIMENTAL

12 Week Exercise Program

Intervention Type OTHER

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.

Interventions

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12 Week Exercise Program

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ONS Foundation

UNKNOWN

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cindy Tofthagen, Ph.D., ARNP

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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MCC-16557

Identifier Type: -

Identifier Source: org_study_id