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Testing av effekten av trening på kjemoterapi-indusert perifer nevropati (CIPN)

24. september 2026 oppdatert av: Po-Ju Lin, University of Rochester NCORP Research Base

Multi-senter randomisert kontrollert fase II studie av trening for å behandle kjemoterapi-indusert perifer nevropati (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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

133

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Annen: Questionnaire Administration

Ancillary studies

Annen: Exercise Counseling

Meet with certified exercise instructor

Annen: Exercise Intervention

Participate in the EXCAP program

Annen: Neuropathy Assessment

Undergo tactile sensitivity test

Andre navn:
  • Vurdering for nevropatiske smerter
Aktiv komparator: 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.
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Annen: Questionnaire Administration

Ancillary studies

Annen: Exercise Counseling

Meet with certified exercise instructor

Annen: Exercise Intervention

Participate in the EXCAP program

Annen: Neuropathy Assessment

Undergo tactile sensitivity test

Andre navn:
  • Vurdering for nevropatiske smerter
Annen: Best Practice

Receive standard of care

Andre navn:
  • velferdstandard
  • standard terapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effects of exercise on the severity of CIPN symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Rochester NCORP Research Base

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. februar 2022

Primær fullføring (Faktiske)

23. april 2026

Studiet fullført (Antatt)

31. januar 2027

Datoer for studieregistrering

Først innsendt

11. mai 2021

Først innsendt som oppfylte QC-kriteriene

11. mai 2021

Først lagt ut (Faktiske)

17. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • URCC19075
  • UG1CA189961 (U.S. NIH-stipend/kontrakt)
  • URCC19075 (Annen identifikator: University of Rochester NCORP Research Base)
  • NCI-2020-11456 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • URCC-19075 (Annen identifikator: CTEP)
  • R21CA256154 (U.S. NIH-stipend/kontrakt)
  • URCC-19075 (Annen identifikator: DCP)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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