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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422993
• Other study ID #: MCC-16557
• Status: Completed
• Phase: N/A
• First received: August 23, 2011
• Last updated: December 28, 2016
• Start date: July 2011
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	ONS Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 Months	No
Secondary	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.	10 Months	Yes
Secondary	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.	10 Months	No

External Links

•   Moffitt Cancer Center Clinical Trials website