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Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

14. november 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

21

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
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53715
        • UW Health Oncology - 1 South Park
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin, Madison

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

Ja

Kjønn som er kvalifisert for studier

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

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: laboratoriebiomarkøranalyse
Korrelative studier
Fremgangsmåte: livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • livskvalitetsvurdering
Atferdsmessig: 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.
Annen: laboratoriebiomarkøranalyse
Korrelative studier
Fremgangsmåte: livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • livskvalitetsvurdering
Fremgangsmåte: standard follow-up care
Receive usual care

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

University of Wisconsin, Madison

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Toby Campbell, University of Wisconsin, Madison

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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

1. desember 2013

Primær fullføring (Faktiske)

1. juli 2015

Studiet fullført (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først innsendt

25. november 2013

Først innsendt som oppfylte QC-kriteriene

25. november 2013

Først lagt ut (Anslag)

3. desember 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. november 2019

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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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