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Exercise During Active Surveillance for Prostate Cancer (ERASE)

8. april 2022 oppdatert av: University of Alberta

A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance

The broad goal of the Exercise During Active Surveillance for Prostate Cancer (ERASE) trial is to examine the effects of exercise in prostate cancer patients undergoing active surveillance.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The ERASE Trial will be a phase II randomized controlled trial. A total of 66 men with low- or intermediate-grade clinically localized prostate cancer undergoing active surveillance will be randomized to either a 12-week of supervised high-intensity aerobic interval training or usual care. The primary outcome will be peak oxygen consumption (VO2peak) as a measure of physical fitness. The secondary outcomes include tumour-related biomarkers, fear of cancer progression, quality of life, and psychological distress. Exploratory outcomes will include indicators of cancer progression including prostate-specific antigen. Based on this sample size, our study has 80% power with a two-tailed alpha <0.05 to detect a clinically meaningful effect of 3.5 ml/kg/min on our primary outcome of VO2max. This power will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes if the effects are at least moderate (i.e., a standardized effect size of d=0.60).

Studietype

Intervensjonell

Registrering (Faktiske)

52

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2H9
        • University of Alberta

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

Mann

Beskrivelse

Inclusion Criteria:

  • ≥18 years of age
  • diagnosed with low or favorable intermediate grade localized PCa defined as PSA less than 10, Gleason Score 3+3 or 3+4 with low volume, and digital rectal examination (DRE) of T1C or T2A
  • initiating or continuing active surveillance with no plans for treatment for prostate cancer in the next 6 months (e.g., radical prostatectomy, radiotherapy, or androgen deprivation therapy)
  • screened for medical clearance for exercise testing and participation in vigorous aerobic exercise
  • residing in a commutable area near Edmonton, Alberta
  • willing to commute to the Behavioural Medicine Fitness Centre three times per week to attend a 12-week supervised high-intensity aerobic interval exercise program

Exclusion Criteria:

  • having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise (e.g., known cardiac disease or uncontrolled hypertension)
  • having contraindications for cardiopulmonary stress and/or physical fitness tests
  • currently participating in a structured, vigorous exercise program.

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: Exercise Group
Supervised high-intensity aerobic interval training (HIIT) during active surveillance
Atferdsmessig: High-intensity aerobic interval training (HIIT)
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
Ingen inngripen: Usual Care Group
The usual care group will be provided with standard active surveillance medical care.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes of Peak Oxygen Consumption (VO2peak)
Tidsramme: At baseline and 12-week (postintervention)
VO2peak is a measure of cardiopulmonary fitness and a powerful surrogate outcome for cancer-specific and overall survival. VO2peak will be defined as the highest oxygen-uptake value recorded during the test and quantified where participants reach a plateau in oxygen consumption, which will be expressed as relative to body mass (i.e., ml O2·kg-1·min-1).
At baseline and 12-week (postintervention)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
Tidsramme: At baseline and 12-week (postintervention)
NKCA significantly contributes to the regulation of tumour suppression in response to exercise and it has been demonstrated to have a diagnostic value in patients with cancer. NK cell activities are assessed using blood analysis as the total number of circulating NK cells and their cytotoxic activity. NK cell counts and NKCA will be measured using the phenotypic markers of NK cells (CD3-CD16+CD56+). NKCA will be expressed as the percentage of target cells killed by a sample of 100,000 peripheral blood mononuclear cells at the effector-to-target ratios of 5:1, 20:1, 40:1, and 100:1.
At baseline and 12-week (postintervention)
Changes of Immune-Related Phenotype
Tidsramme: At baseline and 12-week (postintervention)
Immune-related phenotypic markers, including CD3, CD16, CD56, and CD107 (on the frozen) and CD4, CD8, CD20, CD25, CD11, CD45RA, CD45RO, CD16, CD56, CD107 activation (fresh on whole blood), will be assessed using blood samples.
At baseline and 12-week (postintervention)
Changes of Prostate-Specific Antigen (PSA)
Tidsramme: At baseline, 12-week (postintervention)
PSA will be assessed using blood samples.
At baseline, 12-week (postintervention)
Changes of Complete Blood Count with Differential (CBCD)
Tidsramme: At baseline and 12-week (postintervention)
CBCD, including RBC, WBC, HGB, HCT, PLT, LYMPH, BASO, EOS, MONO, NEUT, will be assessed using blood samples.
At baseline and 12-week (postintervention)
Changes of Insulin
Tidsramme: At baseline and 12-week (postintervention)
Fasting insulin levels will be assessed using blood samples.
At baseline and 12-week (postintervention)
Changes of Fasting Glucose
Tidsramme: At Baseline and 12-week postintervention
Fasting glucose levels will be assessed using blood samples.
At Baseline and 12-week postintervention
Changes of HbA1c
Tidsramme: At Baseline and 12-week postintervention
HbA1c will be assessed using using blood samples.
At Baseline and 12-week postintervention
Changes of Insulin-like Growth Factor (IGF)-axis
Tidsramme: At baseline and 12-week (postintervention)
IGF-axis, including circulating IGF-1 and IGF binding protein(IGFBP)-3, will be assessed using blood samples.
At baseline and 12-week (postintervention)
Changes of Pro-Inflammatory Cytokines
Tidsramme: At baseline and 12-week (postintervention)
Pro-inflammatory cytokines, including IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α, will be assessed.
At baseline and 12-week (postintervention)
Changes of High-Sensitivity C-Reactive Protein (hs-CRP)
Tidsramme: At Baseline and 12-week postintervention
hs-CRP will be assessed using blood samples.
At Baseline and 12-week postintervention
Changes of Adiponectin
Tidsramme: At Baseline and 12-week postintervention
Adiponectin will be assessed using blood samples.
At Baseline and 12-week postintervention
Physical Function
Tidsramme: At Baseline and 12-week postintervention
Physical function, consisting of strength, flexibility, and agility components, will be assessed by the Senior's Fitness Test (SFT).
At Baseline and 12-week postintervention
Health-Related Quality of Life
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Health-related quality of life will be assessed using the European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire (EORTC-QLQ) - C30 questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Prostate Cancer-Specific Quality of Life
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Prostate cancer-specific quality of life will be assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Fear of Cancer Progression
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Fear of cancer progression will be assessed using the Fear of Cancer Recurrence Inventory (FCRI) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Cancer Worry
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
General Anxiety
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
General anxiety will be assessed using the Anxiety (general): Spielberger State-Trait Anxiety Inventory (STAI) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Prostate Cancer-Specific Anxiety
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Prostate cancer-specific anxiety will be assessed using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Depression
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Perceived Stress
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Self-esteem
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Fatigue
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Fatigue will be assessed using the Functional Assessment of Cancer Therapy- Fatigue (FACT-F) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Physical Activity Level
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Physical activity level, consisting of light-, moderate-, and vigorous aerobic exercise and resistance exercise, will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ).
At baseline, 12-week (postintervention), 6-month, and 12-month
Exercise Motivation
Tidsramme: At baseline, 12-week (postintervention), 6-month, and 12-month
Exercise motivation, consisting of Theory of Planned Behaviour (TPB) constructs (instrumental and affective attitudes, subjective norms, intention and perceived behavioral control), will be assessed using questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Body composition
Tidsramme: At baseline and 12-week (postintervention)
Body composition, including body weight and waist- and hip-circumferences, will be assessed using weight scales and a tape measure.
At baseline and 12-week (postintervention)

Samarbeidspartnere og etterforskere

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

Sponsor

University of Alberta

Etterforskere

  • Hovedetterforsker: Kerry S Courneya, PhD, University of Alberta

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.

Generelle publikasjoner

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)

1. juli 2018

Primær fullføring (Faktiske)

31. mai 2020

Studiet fullført (Faktiske)

31. mai 2021

Datoer for studieregistrering

Først innsendt

20. juni 2017

Først innsendt som oppfylte QC-kriteriene

28. juni 2017

Først lagt ut (Faktiske)

29. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. april 2022

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HREBA.CC-17-0248

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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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