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

This study is currently recruiting participants.
Verified March 2013 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Collaborator:
ONS Foundation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01422993
First received: August 23, 2011
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Neuropathy
Gastrointestinal Cancer
 Other: 12 Week Exercise Program

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Number of Screened Patients Who Participate and Complete the Study [ Time Frame: 10 Months ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Who Experience Side Effects [ Time Frame: 10 Months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Measured Improvement [ Time Frame: 10 Months ] [ Designated as safety issue: No ]
    Treatment-effect size will be evaluated by means of changes in muscle strength, balance, and neuropathy from the beginning to completion of the study.


Estimated Enrollment: 12
Study Start Date: July 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Excercise Program
Exercise 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422993

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Cindy Tofthagen, Ph.D., ARNP     813-396-9441     ctofthag@health.usf.edu    
Principal Investigator: Cindy Tofthagen, Ph.D., ARNP            
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
ONS Foundation
Investigators
Principal Investigator: Cindy Tofthagen, Ph.D., ARNP University of South Florida
  More Information

Additional Information:
Moffitt Cancer Center Clinical Trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01422993     History of Changes
Other Study ID Numbers: MCC-16557
Study First Received: August 23, 2011
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Gastrointestinal Neoplasms
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
 Substance-Related Disorders
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013