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Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

14. november 2019 opdateret af: University of Wisconsin, Madison
This randomized pilot clinical trial studies exercise intervention in improving quality of life and exercise capacity and reducing inflammation and oxidative stress in patients with lung cancer and their support persons. Exercise therapy may help improve quality of life, may increase exercise capacity, and may reduce inflammation and oxidative stress in patients with lung cancer and their supporters.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. Determine the effect of an eight-week exercise intervention on biomarkers of inflammation, oxidative stress, exercise capacity, and quality of life in lung cancer patients.

SECONDARY OBJECTIVES:

I. Determine the effect of an eight-week exercise intervention on markers of stress and quality of life in the support person of lung cancer patients.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the University of Wisconsin Hospital and Clinic (UWHC) and 3 days a week at home over 8 weeks.

ARM B: Patients and their support persons undergo the usual care over 8 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53715
        • UW Health Oncology - 1 South Park
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin, Madison

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • LUNG CANCER PATIENTS: A confirmed diagnosis of any stage lung cancer (non-small cell lung cancer [NSCLC] or small cell lung cancer [SCLC])
  • LUNG CANCER PATIENTS: Can be receiving any type of treatment (chemotherapy, radiation therapy, both or neither) are eligible
  • LUNG CANCER PATIENTS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
  • LUNG CANCER PATIENTS: For patients treated with curative intent, and who have not relapsed, they must be within 1 year of their diagnosis of lung cancer (determined by date of diagnostic pathology sample)
  • SUPPORT PERSONS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires

Exclusion Criteria:

  • LUNG CANCER PATIENTS: Symptomatic heart disease including congestive heart failure or arrhythmia
  • LUNG CANCER PATIENTS: Documented myocardial infarction in the last three months
  • LUNG CANCER PATIENTS: Central nervous system (CNS) metastases that results in impaired ability to participate in an exercise program at the discretion of the study physician
  • LUNG CANCER PATIENTS: Any psychological or physical disease that would impair or prevent participation in an exercise program at the discretion of the study physician
  • LUNG CANCER PATIENTS: Cognitive or reading impairments that would preclude them from completing questionnaires
  • LUNG CANCER PATIENTS: Current participation in an exercise program
  • SUPPORT PERSONS: Symptomatic heart disease including congestive heart failure or arrhythmia
  • SUPPORT PERSONS: Documented myocardial infarction in the last three months
  • SUPPORT PERSONS: Cognitive or reading impairments that would preclude them from completing questionnaires

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A (aerobic and exercise training)
Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the UWHC and 3 days a week at home over 8 weeks.
Andet: laboratoriebiomarkøranalyse
Korrelative undersøgelser
Procedure: livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • livskvalitetsvurdering
Adfærdsmæssigt: exercise intervention
Receive aerobic and exercise intervention
Aktiv komparator: Arm II (usual care)
Patients and their support persons undergo the usual care over 8 weeks.
Andet: laboratoriebiomarkøranalyse
Korrelative undersøgelser
Procedure: livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • livskvalitetsvurdering
Procedure: standard follow-up care
Receive usual care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in biomarkers of inflammation
Tidsramme: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Baseline up to 8 weeks
Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG)
Tidsramme: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Baseline up to 8 weeks
Change in time to walk 400 m
Tidsramme: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Baseline up to 8 weeks
Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L)
Tidsramme: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Baseline up to 8 weeks
Change in functional well-being scores on the FACT-L
Tidsramme: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Baseline up to 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in stress scores on the SF-36
Tidsramme: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Baseline up to 8 weeks
Change in quality-of-life scores on the SF-36
Tidsramme: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Baseline up to 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Wisconsin, Madison

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Toby Campbell, University of Wisconsin, Madison

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2013

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

25. november 2013

Først indsendt, der opfyldte QC-kriterier

25. november 2013

Først opslået (Skøn)

3. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2019

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UW13034 (Anden identifikator: University of Wisconsin Carbone Cancer Center)
  • P30CA014520 (U.S. NIH-bevilling/kontrakt)
  • A534260 (Anden identifikator: UW Madison)
  • SMPH\MEDICINE\HEM-ONC (Anden identifikator: UW Madison)
  • 2013-0752 (Anden identifikator: Institutional Review Board)
  • NCI-2013-02185 (Registry Identifier: NCI Trial ID)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med laboratoriebiomarkøranalyse

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Macedonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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