Exercise and Nutrition Interventions During Chemotherapy



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:June 28, 2017
End Date:May 2019

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A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry

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).

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.

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.
We found this trial at
1
site
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-273-3256
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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