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Clinical Trials/NCT01422993
NCT01422993
Completed
N/A

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

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country4 target enrollmentJuly 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neuropathy
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
4
Locations
1
Primary Endpoint
Number of Screened Patients Who Participate and Complete the Study
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of Screened Patients Who Participate and Complete the Study

Time Frame: 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 Outcomes

  • Number of Participants With Measured Improvement(10 Months)
  • Number of Participants Who Experience Side Effects(10 Months)

Study Sites (1)

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