Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy

April 2, 2024 updated by: Po-Ju Lin, University of Rochester NCORP Research Base

Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)

This phase II trial studies whether using exercise is better than the usual approach for treating chemotherapy-induced peripheral neuropathy (CIPN). CIPN occurs when chemotherapy damages the nerves communicating between the brain, spinal cord, and the rest of the body. The usual approach for treating CIPN is treatment with drugs that help reduce symptoms of other types of neuropathy (for example, from diabetes). However, these drugs do not treat all symptoms of CIPN. Exercise may help to reduce CIPN symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

Assess the preliminary efficacy of exercise vs. standard care for treating CIPN (via patient-reported CIPN-20 total score).

SECONDARY OBJECTIVES:

I. Assess the preliminary efficacy of exercise vs. standard care on individual symptoms of CIPN (via CIPN Symptom Inventory; i.e., numbness, tingling, burning/shooting pain, and cramping in the hands and feet).

II. Assess the preliminary efficacy of exercise vs. standard care on a clinical test of CIPN symptoms (via the tactile sensitivity in the fingers and toes).

III. Assess the effects of exercise vs. standard care on possible CIPN mechanisms, namely interoception (via MAIA-2 questionnaire and/or insula-precuneus and insula-thalamus connectivity from brain fMRI).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1 Exercise Intervention Participants receive a 6-week home-based individually tailored progressive intervention, Exercise for Cancer Patients (EXCAP©®), consisting of walking and resistance band exercises. Participants receive an EXCAP kit, which includes an activity tracker, EXCAP manual, and resistance bands, meet with a certified exercise instructor for ~1 hour, and receive individualized walking and resistance band prescriptions. To enhance adherence to EXCAP intervention, the exercise instructor will conduct 2 additional Booster Meetings, each lasting 15-30 minutes, with participants during weeks 2 or 3 and weeks 4 or 5.

Participants will complete REDCap questionnaires and touch tests at baseline and post-intervention. Participants will also wear activity trackers and complete daily diary during the entire study period.

Participants may optionally complete magnetic resonance imaging (MRI) scans on the study.

ARM 2 Control condition (standard care) Participants receive their standard care. Participants will complete REDCap questionnaires and touch tests and wear activity trackers at baseline and post-intervention. Participants will also complete daily diary during the entire study period.

Participants may optionally complete magnetic resonance imaging (MRI) scans on the study.

Participants will be provided with the EXCAP©® program (i.e., EXCAP©® kit and all materials, one EXCAP©® teaching session with exercise instructor, and two Booster Meetings) after all study requirements have been completed at no cost to them.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Decatur, Illinois, United States, 62526
      • Decatur, Illinois, United States, 62526
      • Decatur, Illinois, United States, 62526
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
      • Fridley, Minnesota, United States, 55432
      • Saint Louis Park, Minnesota, United States, 55416
      • Saint Paul, Minnesota, United States, 55101
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Contact:
          • Phone Number: 314-996-5569
    • North Carolina
      • Rocky Mount, North Carolina, United States, 27804
        • Recruiting
        • Nash General Hospital
        • Contact:
          • Phone Number: 252-952-8000
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Not yet recruiting
        • Dayton Clinical Oncology Program
        • Contact:
    • Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Have a diagnosis of cancer.
  2. Have received an infusion of neurotoxic chemotherapy within the past nine months (could still be on chemotherapy or have already completed chemotherapy; i.e., taxane-, platinum-, vinca alkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy).
  3. Report one or more symptoms of CIPN at a level of ≥4 on the CIPN symptom inventory on the Screening Form.
  4. Have an ECOG Performance Status 0-1.
  5. Have at least six months life expectancy.
  6. Be at least 18 years of age.
  7. Be able to read and understand English.
  8. Be able to provide written informed consent.

Exclusion Criteria:

  1. Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance exercise program, according to the patient's physician (e.g., oncologist, primary care) or physician's designee.
  2. Be identified as in the active or maintenance stage of exercise behavior per the Exercise Stages of Change Question on the Screening Form.

  3. Have planned surgery or radiation treatment during the course of the study (hormonal and biologic therapy is allowed).

    Additional exclusion criteria only for patients completing optional brain MRI scans

  4. Have contraindications for MRI scanning, per the MRI safety screening procedures of the MRI facility to be utilized for this participant.
  5. Are pregnant or have plans to become pregnant during the course of the study. Documentation of pregnancy and use of contraception can be obtained from the medical record.
  6. Have a current or prior cancer in the central nervous system (spine, brainstem, brain) as this would interfere with assessments of brain functional connectivity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 Exercise Intervention- EXCAP

Participants receive a 6-week home-based individually tailored progressive intervention, Exercise for Cancer Patients (EXCAP©®), consisting of walking and resistance band exercises. Participants receive an EXCAP kit, which includes an activity tracker, EXCAP manual, and resistance bands, meet with a certified exercise instructor for ~1 hour, and receive individualized walking and resistance band prescriptions. To enhance adherence to EXCAP intervention, the exercise instructor will conduct 2 additional Booster Meetings, each lasting 15-30 minutes, with participants during weeks 2 or 3 and weeks 4 or 5.

Participants will complete REDCap questionnaires and touch tests at baseline and post-intervention. Participants will also wear activity trackers and complete daily diary during the entire study period.

Participants may optionally complete magnetic resonance imaging (MRI) scans on the study.
Behavioral: Exercise Intervention
Participate in the Exercise for Cancer Patients (EXCAP) intervention
Other: Tactile Sensitivity Test
Participants undergo tactile sensitivity test
Other Names:
  • Touch Test
Other: Questionnaire Administration
Participants complete questionnaires
Procedure: Brain Magnetic Resonance Imaging
Participants may have options to complete brain MRI scans
Other Names:
  • fMRI
Active Comparator: Arm 2 Control condition (standard care)

Participants receive their standard care. Participants will complete REDCap questionnaires and touch tests and wear activity trackers at baseline and post-intervention. Participants will also complete daily diary during the entire study period.

Participants may optionally complete magnetic resonance imaging (MRI) scans on the study.

Participants will be provided with the EXCAP©® program (i.e., EXCAP©® kit and all materials, one EXCAP©® teaching session with exercise instructor, and two Booster Meetings) after all study requirements have been completed at no cost to them.
Other: Tactile Sensitivity Test
Participants undergo tactile sensitivity test
Other Names:
  • Touch Test
Other: Questionnaire Administration
Participants complete questionnaires
Procedure: Brain Magnetic Resonance Imaging
Participants may have options to complete brain MRI scans
Other Names:
  • fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity
Time Frame: Up to 6 weeks post randomization
Will estimate the effects of exercise versus usual care on CIPN (measured via CIPN-20) using analysis of covariance (ANCOVA). The model will include CIPN-20 at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable of interest, and the pre-intervention CIPN-20 score as a covariate.
Up to 6 weeks post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of exercise on CIPN symptoms
Time Frame: Up to 6 weeks post randomization
We will conduct ANCOVA analyses to assess the effects of exercise versus usual care on each individual symptom of CIPN from the daily CIPN symptom inventory. The outcome for each symptom is the average of all 7 days of values at Week 6. The model will include each CIPN symptom at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention CIPN symptom as a covariate.
Up to 6 weeks post randomization
Effect of exercise on tactile sensitivity
Time Frame: Up to 6 weeks post randomization
We will conduct ANCOVA analyses to assess the effects of exercise on tactile sensitivity in the finger and tactile sensitivity in the toe from the touch test. The model will include tactile sensitivity in the finger at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention tactile sensitivity in the finger as a covariate. The model will include tactile sensitivity in the toe at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention tactile sensitivity in the toe as a covariate.
Up to 6 weeks post randomization
Effect of exercise on interoception
Time Frame: Up to 6 weeks post randomization

We will conduct ANCOVA analyses to assess the effect of exercise on interoception (assessed via MAIA-2). The model will include MAIA-2 total score at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable of interest, and the pre-intervention MAIA-2 total score as a covariate.

*Optional We will use ANCOVA analyses to test for the effect of exercise on interception from brain fMRI. The outcome is insula-precuneus and insula-thalamus connectivity. The model will include insula-precuneus connectivity at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention insula-precuneus connectivity as a covariate.

The model will include insula-thalamus connectivity at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention insula-thalamus connectivity as a covariate.
Up to 6 weeks post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester NCORP Research Base

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Po-Ju Lin, PhD, MPH, University of Rochester NCORP Research Base
  • Principal Investigator: Ian Kleckner, PhD, MPH, University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

January 2, 2026

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URCC19075 (Other Identifier: University of Rochester NCORP Research Base)
  • UG1CA189961 (U.S. NIH Grant/Contract)
  • NCI-2020-11456 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • URCC-19075 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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