Exercise and Nutrition Interventions During Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2018-10-11

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).

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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.

Conditions

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Neuropathy;Peripheral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise

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.

Group Type EXPERIMENTAL

EXCAP Exercise

Intervention Type BEHAVIORAL

12 weeks of at-home walking and resistance exercise

Nutrition Education Control

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.

Group Type ACTIVE_COMPARATOR

Nutrition Education Control

Intervention Type BEHAVIORAL

12 weeks of implementing eating tips

Interventions

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EXCAP Exercise

12 weeks of at-home walking and resistance exercise

Intervention Type BEHAVIORAL

Nutrition Education Control

12 weeks of implementing eating tips

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No