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Testen van de effecten van lichaamsbeweging op door chemotherapie geïnduceerde perifere neuropathie (CIPN)

24 september 2026 bijgewerkt door: Po-Ju Lin, University of Rochester NCORP Research Base

Multi-center gerandomiseerde gecontroleerde fase II-studie van inspanning om door chemotherapie geïnduceerde perifere neuropathie (CIPN) te behandelen

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

133

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Ander: Questionnaire Administration

Ancillary studies

Ander: Exercise Counseling

Meet with certified exercise instructor

Ander: Exercise Intervention

Participate in the EXCAP program

Ander: Neuropathy Assessment

Undergo tactile sensitivity test

Andere namen:
  • Beoordeling voor neuropathische pijn
Actieve vergelijker: 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.
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Ander: Questionnaire Administration

Ancillary studies

Ander: Exercise Counseling

Meet with certified exercise instructor

Ander: Exercise Intervention

Participate in the EXCAP program

Ander: Neuropathy Assessment

Undergo tactile sensitivity test

Andere namen:
  • Beoordeling voor neuropathische pijn
Ander: Best Practice

Receive standard of care

Andere namen:
  • zorgstandaard
  • standaard therapie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity
Tijdsspanne: Week 6 post randomization

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effects of exercise on the severity of CIPN symptoms
Tijdsspanne: Up to 6 weeks post randomization

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
Tijdsspanne: Up to 6 weeks post randomization

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
Tijdsspanne: Up to 6 weeks post randomization

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Rochester NCORP Research Base

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Ian R Kleckner, University of Rochester NCORP Research Base

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 februari 2022

Primaire voltooiing (Werkelijk)

23 april 2026

Studie voltooiing (Geschat)

31 januari 2027

Studieregistratiedata

Eerst ingediend

11 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria

11 mei 2021

Eerst geplaatst (Werkelijk)

17 mei 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • URCC19075
  • UG1CA189961 (Subsidie/contract van de Amerikaanse NIH)
  • URCC19075 (Andere identificatie: University of Rochester NCORP Research Base)
  • NCI-2020-11456 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • URCC-19075 (Andere identificatie: CTEP)
  • R21CA256154 (Subsidie/contract van de Amerikaanse NIH)
  • URCC-19075 (Andere identificatie: DCP)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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