ACTIVE_NOT_RECRUITING

Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy

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Conditions

Chemotherapy-Induced Peripheral NeuropathyHematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-25
Study Completion:2025-11-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04888988

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of cancer
  2. * 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
  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 Eastern Cooperative Oncology Group (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
  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 participant'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)
  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 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.
  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.

Contacts and Locations

Principal Investigator

Ian R Kleckner
PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Rochester NCORP Research Base

  • Ian R Kleckner, PRINCIPAL_INVESTIGATOR, University of Rochester NCORP Research Base

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 Registration Dates

Study Start Date2022-02-25
Study Completion Date2025-11-07

Study Record Updates

Study Start Date2022-02-25
Study Completion Date2025-11-07

Terms related to this study

Additional Relevant MeSH Terms

  • Chemotherapy-Induced Peripheral Neuropathy
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm