Back to resultsPilot Study of Strength and Balance Training Program for Persons With Oxaliplatin Induced Neuropathy
Primary Purpose
Neuropathy, Gastrointestinal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12 Week Exercise Program
Sponsored by
About this trial
This is an interventional supportive care trial for Neuropathy focused on measuring Oxaliplatin Induced, Peripheral Neuropathy, Strength, Balance, Training Program, Colon, Rectal
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.
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Excercise and Questionnaire
Arm Description
12 week exercise program followed by questionnaire.
Outcomes
Primary Outcome Measures
Number of Screened Patients Who Participate and Complete the Study
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
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
Treatment-effect size will be evaluated by means of changes in muscle strength, balance, and neuropathy from the beginning to completion of the study.
Full Information
NCT ID
NCT01422993
First Posted
August 23, 2011
Last Updated
December 28, 2016
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
ONS Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01422993
Brief Title
Pilot Study of Strength and Balance Training Program for Persons With Oxaliplatin Induced Neuropathy
Official Title
A Pilot Study of a Strength and Balance Training Program for Persons With Oxaliplatin Induced Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
ONS Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy, Gastrointestinal Cancer
Keywords
Oxaliplatin Induced, Peripheral Neuropathy, Strength, Balance, Training Program, Colon, Rectal
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Excercise and Questionnaire
Arm Type
Experimental
Arm Description
12 week exercise program followed by questionnaire.
Intervention Type
Other
Intervention Name(s)
12 Week Exercise Program
Intervention Description
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 Measure Information:
Title
Number of Screened Patients Who Participate and Complete the Study
Description
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.
Time Frame
10 Months
Secondary Outcome Measure Information:
Title
Number of Participants Who Experience Side Effects
Description
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.
Time Frame
10 Months
Title
Number of Participants With Measured Improvement
Description
Treatment-effect size will be evaluated by means of changes in muscle strength, balance, and neuropathy from the beginning to completion of the study.
Time Frame
10 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy Tofthagen, Ph.D., ARNP
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Strength and Balance Training Program for Persons With Oxaliplatin Induced Neuropathy
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