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).
Behavioral: EXCAP Exercise
Behavioral: Nutrition Education Control
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Locations near you
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Full eligibility criteria for NCT03021174
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
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.
All locations for NCT03021174
United States (1)
University of Rochester Medical Center
Rochester, New York, United States, 14642
View full eligibility
Tris trial is registered with FDA with number: NCT03021174. The sponsor of the trial is University of Rochester and it is looking for 21 volunteers for the current phase.
Official trial title: A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
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