Back to resultsExercise and Nutrition Interventions During Chemotherapy
Primary Purpose
Neuropathy;Peripheral
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EXCAP Exercise
Nutrition Education Control
Sponsored by
About this trial
This is an interventional prevention trial for Neuropathy;Peripheral focused on measuring CIPN, Chemotherapy-induced peripheral neuropathy
Eligibility Criteria
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.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise
Nutrition Education Control
Arm 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.
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.
Outcomes
Primary Outcome Measures
Percent of patients screened who are eligible
Number of patients eligible divided by number of patients screened
Percent of patients eligible who are consented
Number of patients consented divided by number of patients approached
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
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03021174
First Posted
January 11, 2017
Last Updated
July 16, 2019
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT03021174
Brief Title
Exercise and Nutrition Interventions During Chemotherapy
Official Title
A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
October 11, 2018 (Actual)
Study Completion Date
October 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy;Peripheral
Keywords
CIPN, Chemotherapy-induced peripheral neuropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm 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.
Arm Title
Nutrition Education Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
EXCAP Exercise
Intervention Description
12 weeks of at-home walking and resistance exercise
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education Control
Intervention Description
12 weeks of implementing eating tips
Primary Outcome Measure Information:
Title
Percent of patients screened who are eligible
Description
Number of patients eligible divided by number of patients screened
Time Frame
12 weeks
Title
Percent of patients eligible who are consented
Description
Number of patients consented divided by number of patients approached
Time Frame
12 weeks
Title
Percent of patients consented who complete the exercise intervention
Description
Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm
Time Frame
12 weeks
Title
Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy
Description
Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Interested researchers may contact the study PI with requests for collaboration.
Learn more about this trial
Exercise and Nutrition Interventions During Chemotherapy
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