Overview

This trial is active, not recruiting.

Conditions neuropathy, gastrointestinal cancer
Treatment 12 week exercise program
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator ONS Foundation
Start date July 2011
End date June 2017
Trial size 4 participants
Trial identifier NCT01422993, MCC-16557

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
12 week exercise program followed by questionnaire.
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.

Primary Outcomes

Measure
Number of Screened Patients Who Participate and Complete the Study
time frame: 10 Months

Secondary Outcomes

Measure
Number of Participants Who Experience Side Effects
time frame: 10 Months
Number of Participants With Measured Improvement
time frame: 10 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Pilot Study of a Strength and Balance Training Program for Persons With Oxaliplatin Induced Peripheral Neuropathy
Principal investigator Cindy Tofthagen, Ph.D., ARNP
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.