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

Not Applicable

Completed

• Conditions: Neuropathy; Gastrointestinal Cancer
• Interventions: Other: 12 Week Exercise Program

• Registration Number: NCT01422993
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-24
• Study First Posted: 2011-08-25
• Primary Completion: 2016-04
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Excercise and Questionnaire	12 Week Exercise Program	12 week exercise program followed by questionnaire.

Primary Outcome Measures

Name	Time	Method
Number of Screened Patients Who Participate and Complete the Study	10 Months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Measured Improvement	10 Months	Treatment-effect size will be evaluated by means of changes in muscle strength, balance, and neuropathy from the beginning to completion of the study.
Number of Participants Who Experience Side Effects	10 Months	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.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States