Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy (CIPN)

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: Active, not recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Chemotherapy-Induced Peripheral Neuropathy
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Magnetic Resonance Imaging; Other: Best Practice; Other: Exercise Counseling; Other: Exercise Intervention; Other: Neuropathy Assessment

Detailed Description

PRIMARY OBJECTIVE:

I. Assess the preliminary efficacy of exercise versus (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 two possible CIPN mechanisms, namely interoception (via Multidimensional Assessment of Interoceptive Awareness version 2 [MAIA-2] questionnaire).

EXPLORATORY OBJECTIVES:

I. Assess the effects of exercise vs. standard care on other common symptoms related to cancer, chemotherapy, and CIPN, including:

Ia. Daily Diary of symptoms of CIPN. Ib. An array of cancer and treatment symptoms (MD Anderson Symptom Inventory; MDASI).

Ic. Anxiety and depression (hospital anxiety and depression scale; HADS). Id. Pain catastrophizing (pain catastrophizing scale; PCS). Ie. Cognitive impairment (Functional Assessment of Cancer Therapy-Cognitive [FACT-Cog]).

If. Fatigue (brief fatigue inventory; BFI). Ig. Quality of life (Functional Assessment of Cancer Therapy - General [FACT-G]).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM 1 (EXERCISE): Participants undergo the exercise for cancer patients (EXCAP) intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, participants meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5.

ARM 2 (CONTROL): Participants receive usual care for 6 weeks. At the end of the study, participants may receive the exercise kit and complete the EXCAP program as in Arm 1. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes.

Participants may optionally undergo magnetic resonance imaging (MRI) on study.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Kaiser Permanente-Fresno
    • Martinez, California, United States, 94553-3156
      • Contra Costa Regional Medical Center
    • Roseville, California, United States, 95661
      • Kaiser Permanente-Roseville
    • Sacramento, California, United States, 95814
      • Kaiser Permanente Downtown Commons
    • Sacramento, California, United States, 95823
      • Kaiser Permanente-South Sacramento
    • San Jose, California, United States, 95119
      • Kaiser Permanente-Santa Teresa-San Jose
    • San Leandro, California, United States, 94577
      • Kaiser Permanente San Leandro
    • San Rafael, California, United States, 94903
      • Kaiser San Rafael-Gallinas
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Medical Center - Santa Clara
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente-South San Francisco
    • Vallejo, California, United States, 94589
      • Kaiser Permanente-Vallejo
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente-Walnut Creek
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers-Aurora
    • Boulder, Colorado, United States, 80303
      • Boulder Community Foothills Hospital
    • Boulder, Colorado, United States, 80304
      • Rocky Mountain Cancer Centers-Boulder
    • Centennial, Colorado, United States, 80112
      • Rocky Mountain Cancer Centers - Centennial
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers-Midtown
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Centers-Rose
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute
    • Denver, Colorado, United States, 80209
      • The Women's Imaging Center
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Cancer Centers - Swedish
    • Englewood, Colorado, United States, 80113
      • The Melanoma and Skin Cancer Institute
    • Lakewood, Colorado, United States, 80228
      • Rocky Mountain Cancer Centers-Lakewood
    • Littleton, Colorado, United States, 80120
      • Rocky Mountain Cancer Centers-Littleton
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Centers-Sky Ridge
    • Longmont, Colorado, United States, 80501
      • Rocky Mountain Cancer Centers-Longmont
    • Thornton, Colorado, United States, 80260
      • Rocky Mountain Cancer Centers-Thornton
  • Delaware
    • Millville, Delaware, United States, 19967
      • Beebe South Coastal Health Campus
    • Newark, Delaware, United States, 19713
      • Helen F Graham Cancer Center
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants PA
    • Rehoboth Beach, Delaware, United States, 19971
      • Beebe Health Campus
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Cancer Care Inc - Waterfront Plaza
    • Honolulu, Hawaii, United States, 96813
      • Straub Clinic and Hospital
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii Cancer Center
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Medical Center for Women and Children
    • ‘Aiea, Hawaii, United States, 96701
      • Hawaii Cancer Care - Westridge
    • ‘Aiea, Hawaii, United States, 96701
      • Pali Momi Medical Center
  • Illinois
    • Carterville, Illinois, United States, 62918
      • SIH Cancer Institute
    • Centralia, Illinois, United States, 62801
      • Centralia Oncology Clinic
    • Danville, Illinois, United States, 61832
      • Carle at The Riverfront
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital
    • Decatur, Illinois, United States, 62526
      • Cancer Care Specialists of Illinois - Decatur
    • Effingham, Illinois, United States, 62401
      • Crossroads Cancer Center
    • O'Fallon, Illinois, United States, 62269
      • Cancer Care Center of O'Fallon
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Oncology Associates at Mercy Medical Center
    • Cedar Rapids, Iowa, United States, 52402
      • Physicians' Clinic of Iowa PC
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center - Des Moines
  • Maryland
    • Elkton, Maryland, United States, 21921
      • Christiana Care - Union Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
    • Brighton, Michigan, United States, 48114
      • Trinity Health IHA Medical Group Hematology Oncology - Brighton
    • Brighton, Michigan, United States, 48114
      • Trinity Health Medical Center - Brighton
    • Canton, Michigan, United States, 48188
      • Trinity Health IHA Medical Group Hematology Oncology - Canton
    • Canton, Michigan, United States, 48188
      • Trinity Health Medical Center - Canton
    • Chelsea, Michigan, United States, 48118
      • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
    • Chelsea, Michigan, United States, 48118
      • Chelsea Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
    • Lansing, Michigan, United States, 48912
      • University of Michigan Health - Sparrow Lansing
    • Livonia, Michigan, United States, 48154
      • Trinity Health Saint Mary Mercy Livonia Hospital
    • Ypsilanti, Michigan, United States, 48197
      • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Fridley, Minnesota, United States, 55432
      • Unity Hospital
    • Minneapolis, Minnesota, United States, 55407
      • Abbott-Northwestern Hospital
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Clinic - Saint Louis Park
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
    • Waconia, Minnesota, United States, 55387
      • Ridgeview Medical Center
    • Willmar, Minnesota, United States, 56201
      • Rice Memorial Hospital
  • Missouri
    • Osage Beach, Missouri, United States, 65065
      • Lake Regional Hospital
    • St Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • CaroMont Regional Medical Center
    • Lincolnton, North Carolina, United States, 28092
      • CaroMont Health - Lincoln Cancer Center
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth of the Carolinas-Moore Regional Hospital
    • Rocky Mount, North Carolina, United States, 27804
      • Nash UNC HealthCare
  • Ohio
    • Belpre, Ohio, United States, 45714
      • Strecker Cancer Center-Belpre
    • Lancaster, Ohio, United States, 43130
      • Fairfield Medical Center
    • Lima, Ohio, United States, 45801
      • Saint Rita's Medical Center
    • Marietta, Ohio, United States, 45750
      • Marietta Memorial Hospital
    • Newark, Ohio, United States, 43055
      • Licking Memorial Hospital
    • Portsmouth, Ohio, United States, 45662
      • Southern Ohio Medical Center
    • Zanesville, Ohio, United States, 43701
      • Genesis Healthcare System Cancer Care Center
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • Prisma Health Cancer Institute - Spartanburg
    • Easley, South Carolina, United States, 29640
      • Prisma Health Cancer Institute - Easley
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Faris
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Cancer Institute - Eastside
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Butternut
    • Greer, South Carolina, United States, 29650
      • Prisma Health Cancer Institute - Greer
    • Seneca, South Carolina, United States, 29672
      • Prisma Health Cancer Institute - Seneca
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Chesapeake Regional Medical Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Saint Vincent Hospital Cancer Center Green Bay
    • Green Bay, Wisconsin, United States, 54303
      • Saint Vincent Hospital Cancer Center at Saint Mary's
    • Sturgeon Bay, Wisconsin, United States, 54235-1495
      • Saint Vincent Hospital Cancer Center at Sturgeon Bay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a diagnosis of cancer
• Have received 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
• Report one or more symptoms of CIPN at a level of >= 4 on the CIPN symptom inventory on the Screening Form
• Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Have at least six months life expectancy
• Be at least 18 years of age
• Be able to read and understand English
• Be able to provide written informed consent

Exclusion Criteria:

• 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 participant's physician (e.g., oncologist, primary care) or physician's designee
• Be identified as in the active or maintenance stage of exercise behavior per the Exercise Stages of Change Question on the Screening Form
• Have planned surgery or radiation treatment during the course of the study (hormonal and biologic therapy is allowed)
• Have contraindications for MRI scanning, per the MRI safety screening procedures of the MRI facility to be utilized for this participant
• Are pregnant of 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.
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 (EXCAP, tactile sensitivity test, counseling); Participants undergo the EXCAP intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, participants meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5. Participants may optionally undergo MRI on study.	Other: Questionnaire Administration; Ancillary studies; Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic Resonance Imaging (MRI); sMRI; Magnetic resonance imaging (procedure); MRIs; Structural MRI; Other: Exercise Counseling; Meet with certified exercise instructor; Other: Exercise Intervention; Participate in the EXCAP program; Other: Neuropathy Assessment; Undergo tactile sensitivity test; Other Names: Assessment for Neuropathic Pain
Active Comparator: Arm 2 (usual care, tactile sensitivity test); Participants receive usual care for 6 weeks. At the end of the study, participants may receive the exercise kit and complete the EXCAP program as in Arm 1. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. Participants may optionally undergo MRI on study.	Other: Questionnaire Administration; Ancillary studies; Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic Resonance Imaging (MRI); sMRI; Magnetic resonance imaging (procedure); MRIs; Structural MRI; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy; Other: Exercise Counseling; Meet with certified exercise instructor; Other: Exercise Intervention; Participate in the EXCAP program; Other: Neuropathy Assessment; Undergo tactile sensitivity test; Other Names: Assessment for Neuropathic Pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity	Will estimate the effects of exercise versus usual care on CIPN using analysis of covariance (ANCOVA). Will be measured by the mean European Organization for Research and Treatment of Cancer-CIPN20. 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.	Week 6 post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of exercise on the severity of CIPN symptoms	We will estimate the effects of exercise vs. usual care on CIPN symptoms (i.e., hot/burning or sharp/shooting pain in the hands or feet, numbness or tingling in the hands or feet) collected from the daily symptom inventory (0-10 severity) using analysis of covariance (ANCOVA). The model will include the average of daily symptom inventory for each CIPN symptom at post-intervention as the outcome, controlling for the average of daily symptom inventory for each CIPN symptom at pre-intervention.	Up to 6 weeks post randomization
Effects of exercise on tactile sensitivity	We will estimate the effects of exercise vs. usual care on tactile sensitivity in the fingers and toes, assessed via an established touch test procedure with a set of monofilaments, using analysis of covariance (ANCOVA). The model will include the tactile sensitivity score at post-intervention as the outcome, controlling for the pre-intervention score.	Up to 6 weeks post randomization
Effect of exercise on interoception	We will estimate the effects of exercise vs. usual care on interoception, measured via the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), using analysis of covariance (ANCOVA). The model will include the MAIA-2 total score at post-intervention as the outcome, controlling for the pre-intervention MAIA-2 total score.	Up to 6 weeks post randomization

Collaborators and Investigators

• Sponsor: University of Rochester NCORP Research Base
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ian R Kleckner, University of Rochester NCORP Research Base

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): October 20, 2025
• Study Completion (Estimated): June 30, 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 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Therapeutics; Quality of Health Care; Quality Indicators, Health Care; Chemistry Techniques, Analytical; Spectrum Analysis; Behavior Control; Immobilization; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Magnetic Resonance Spectroscopy; Restraint, Physical; Practice Guidelines as Topic
• 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); R21CA256154 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No