Clinical trial NCT03021174: Exercise and Nutrition Interventions During Chemotherapy
Official title: A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathy;Peripheral
Keywords: CIPN
Chemotherapy-induced peripheral neuropathy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of patients screened who are eligible
timeFrame: 12 weeks
measure: Percent of patients eligible who are consented
timeFrame: 12 weeks
measure: Percent of patients consented who complete the exercise intervention
timeFrame: 12 weeks
measure: Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: