Trials / Completed
CompletedNCT03021174
Exercise and Nutrition Interventions During Chemotherapy
A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a feasibility pilot study to initiate a research program to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the hands and feet).
Detailed description
This is a feasibility pilot study to help obtain external funding for a larger study to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (CIPN), which is a dose-limiting and painful side effect of chemotherapy for which there are no established treatments. The investigators will conduct a two-arm randomized clinical trial in 40 cancer patients receiving chemotherapy where Arm 1 is 12 weeks of exercise during chemotherapy and Arm 2 is 12 weeks of nutrition education (control condition) during chemotherapy. The investigators will acquire data on CIPN via patient reports and clinical assessments as well as general pain and hypothetical mechanistic factors that may help explain how exercise may treat CIPN; these factors include measures of musculoskeletal, cardiovascular, neuropsychological, and immunological function. The primary outcomes are related to the feasibility of identifying, recruiting, and obtaining complete data from research participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | EXCAP Exercise | 12 weeks of at-home walking and resistance exercise |
| BEHAVIORAL | Nutrition Education Control | 12 weeks of implementing eating tips |
Timeline
- Start date
- 2017-06-28
- Primary completion
- 2018-10-11
- Completion
- 2018-10-11
- First posted
- 2017-01-13
- Last updated
- 2019-07-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03021174. Inclusion in this directory is not an endorsement.