Exercise and Nutrition Interventions During Chemotherapy

Not Applicable

Completed

• Conditions: Neuropathy;Peripheral

• Registration Number: NCT03021174
• Lead Sponsor: University of Rochester

Brief 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.

Study Timeline

• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Study Start: 2017-06-28
• Primary Completion: 2018-10-11
• Study Completion: 2018-10-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Have non-metastatic cancer
• Be chemotherapy naïve
• Be scheduled to receive CIPN-inducing chemotherapy during the study (platinums, vinca alkaloids, taxanes, thalidomide, or bortezomib) for the duration of the intervention (12 weeks)
• Report symptoms of peripheral neuropathy at baseline (subject-reported severity of numbness and tingling in hands/feet of at least 1 on a 0-10 scale)
• Be able to perform the exercise intervention
• Be able to read English
• Be at least 18 years old (no upper limit on age)
• Be consistently right-handed in daily activities for consistency in reporting any lateralized effects from brain imaging
• Provide written informed consent

Exclusion Criteria

• Receive surgery, radiation, or hormone therapy for their cancer during the study
• Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
• Have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, etc. - note that most port-a-caths are safe for MRI scanning)
• Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent of patients screened who are eligible	12 weeks	Number of patients eligible divided by number of patients screened
Percent of patients eligible who are consented	12 weeks	Number of patients consented divided by number of patients approached
Percent of patients consented who complete the exercise intervention	12 weeks	Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm
Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy	12 weeks	Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms)

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States