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Exercise During Active Surveillance for Prostate Cancer (ERASE)

8 april 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Faktisk)

52

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G2H9
        • University of Alberta

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Exercise Group
Supervised high-intensity aerobic interval training (HIIT) during active surveillance
Beteende: High-intensity aerobic interval training (HIIT)
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
Inget ingripande: Usual Care Group
The usual care group will be provided with standard active surveillance medical care.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes of Peak Oxygen Consumption (VO2peak)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: At Baseline and 12-week postintervention
Fasting glucose levels will be assessed using blood samples.
At Baseline and 12-week postintervention
Changes of HbA1c
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: At Baseline and 12-week postintervention
hs-CRP will be assessed using blood samples.
At Baseline and 12-week postintervention
Changes of Adiponectin
Tidsram: At Baseline and 12-week postintervention
Adiponectin will be assessed using blood samples.
At Baseline and 12-week postintervention
Physical Function
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Alberta

Utredare

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

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2018

Primärt slutförande (Faktisk)

31 maj 2020

Avslutad studie (Faktisk)

31 maj 2021

Studieregistreringsdatum

Först inskickad

20 juni 2017

Först inskickad som uppfyllde QC-kriterierna

28 juni 2017

Första postat (Faktisk)

29 juni 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 april 2022

Senast verifierad

1 november 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HREBA.CC-17-0248

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