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

NCT01422993 | Completed

• 1 other identifier: MCC-16557
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathy; Gastrointestinal Cancer

Keywords

Oxaliplatin Induced; Peripheral Neuropathy; Strength; Balance; Training Program; Colon; Rectal

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of Participants Who Experience Side Effects

  10 Months

• Number of Participants With Measured Improvement

  10 Months

Study Arms (1)

Excercise and Questionnaire

EXPERIMENTAL

12 week exercise program followed by questionnaire.

Other: 12 Week Exercise Program

Interventions

12 Week Exercise Program OTHER

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.

Excercise and Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• ONS Foundation: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Cindy Tofthagen, Ph.D., ARNP

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 25, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

US (1)