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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01422993
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : December 29, 2016
ONS Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Neuropathy Gastrointestinal Cancer Other: 12 Week Exercise Program

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of a Strength and Balance Training Program for Persons With Oxaliplatin Induced Peripheral Neuropathy
Study Start Date : July 2011
Primary Completion Date : April 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Excercise and Questionnaire
12 week exercise program followed by questionnaire.
Other: 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 Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants Who Experience Side Effects [ Time Frame: 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.

  2. Number of Participants With Measured Improvement [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422993

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
ONS Foundation
Principal Investigator: Cindy Tofthagen, Ph.D., ARNP University of South Florida

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01422993     History of Changes
Other Study ID Numbers: MCC-16557
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Oxaliplatin Induced
Peripheral Neuropathy
Training Program

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Gastrointestinal Neoplasms
Neuromuscular Diseases
Nervous System Diseases
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents