Gastrointestinal Cancer, Neuropathy
Conditions
Keywords
Oxaliplatin Induced, Peripheral Neuropathy, Strength, Balance, Training Program, Colon, Rectal
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.
Interventions
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.
Sponsors
ONS Foundation
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Screened Patients Who Participate and Complete the Study | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience Side Effects | 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. |
| Number of Participants With Measured Improvement | 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. |
Countries
United States
Outcome results
None listed