Exercise and Nutrition Interventions During Chemotherapy

University of Rochester

Status: Completed

Conditions: Neuropathy;Peripheral

Treatments: Behavioral: Nutrition Education Control; Behavioral: EXCAP Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03021174

RSRB00066046

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: EXCAP Exercise

Nutrition Education Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Nutrition Education Control