Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy
NCT ID: NCT04888988
Last Updated: 2025-11-21
Study Results
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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ACTIVE_NOT_RECRUITING
NA
133 participants
INTERVENTIONAL
2022-02-25
2026-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Exercise Counseling
Meet with certified exercise instructor
Exercise Intervention
Participate in the EXCAP program
Magnetic Resonance Imaging
Undergo MRI
Neuropathy Assessment
Undergo tactile sensitivity test
Questionnaire Administration
Ancillary studies
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.
Best Practice
Receive standard of care
Exercise Counseling
Meet with certified exercise instructor
Exercise Intervention
Participate in the EXCAP program
Magnetic Resonance Imaging
Undergo MRI
Neuropathy Assessment
Undergo tactile sensitivity test
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive standard of care
Exercise Counseling
Meet with certified exercise instructor
Exercise Intervention
Participate in the EXCAP program
Magnetic Resonance Imaging
Undergo MRI
Neuropathy Assessment
Undergo tactile sensitivity test
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester NCORP Research Base
OTHER
Responsible Party
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Po-Ju Lin
URCC Study Co-Chair
Principal Investigators
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Ian R Kleckner
Role: PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base
Locations
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Kaiser Permanente-Fresno
Fresno, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Kaiser Permanente Downtown Commons
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser San Rafael-Gallinas
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
Boulder Community Foothills Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, United States
The Women's Imaging Center
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
SIH Cancer Institute
Carterville, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Christiana Care - Union Hospital
Elkton, Maryland, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, Michigan, United States
Chelsea Hospital
Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Lake Regional Hospital
Osage Beach, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
CaroMont Regional Medical Center
Gastonia, North Carolina, United States
CaroMont Health - Lincoln Cancer Center
Lincolnton, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Nash UNC HealthCare
Rocky Mount, North Carolina, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Chesapeake Regional Medical Center
Chesapeake, Virginia, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2020-11456
Identifier Type: REGISTRY
Identifier Source: secondary_id
URCC19075
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-19075
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-19075
Identifier Type: OTHER
Identifier Source: secondary_id
URCC19075
Identifier Type: -
Identifier Source: org_study_id
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