Exercise and Nutrition Interventions During Chemotherapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neuropathy;Peripheral

Intervention / Treatment
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* Behavioral: EXCAP Exercise
* Behavioral: Nutrition Education Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercise for Cancer Patients (EXCAP©®), developed by Dr. Karen Mustian, involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program. | Behavioral: EXCAP Exercise<br>* 12 weeks of at-home walking and resistance exercise<br>|
| Active Comparator: Nutrition Education Control<br>Nutrition education (control) involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription. | Behavioral: Nutrition Education Control<br>* 12 weeks of implementing eating tips<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIPN, Chemotherapy-induced peripheral neuropathy