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Exercise During Active Surveillance for Prostate Cancer (ERASE)

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ClinicalTrials.gov Identifier: NCT03203460
Recruitment Status : Active, not recruiting
First Posted : June 29, 2017
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Kerry Courneya, University of Alberta

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
Changes of Peak Oxygen Consumption (VO2peak) [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
Changes of Natural Killer Cell Cytotoxic Activity (NKCA) [ Time Frame: At Baseline and 12-week post-intervention ]
We will assess the changes of NKCA from baseline to 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts [ Time Frame: 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.
  • Changes of Immune-Related Phenotype [ Time Frame: 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.
  • Changes of Prostate-Specific Antigen (PSA) [ Time Frame: At baseline, 12-week (postintervention) ]
    PSA will be assessed using blood samples.
  • Changes of Complete Blood Count with Differential (CBCD) [ Time Frame: At baseline and 12-week (postintervention) ]
    CBCD, including RBC, WBC, HGB, HCT, PLT, LYMPH, BASO, EOS, MONO, NEUT, will be assessed using blood samples.
  • Changes of Insulin [ Time Frame: At baseline and 12-week (postintervention) ]
    Fasting insulin levels will be assessed using blood samples.
  • Changes of Fasting Glucose [ Time Frame: At Baseline and 12-week postintervention ]
    Fasting glucose levels will be assessed using blood samples.
  • Changes of HbA1c [ Time Frame: At Baseline and 12-week postintervention ]
    HbA1c will be assessed using using blood samples.
  • Changes of Insulin-like Growth Factor (IGF)-axis [ Time Frame: At baseline and 12-week (postintervention) ]
    IGF-axis, including circulating IGF-1 and IGF binding protein(IGFBP)-3, will be assessed using blood samples.
  • Changes of Pro-Inflammatory Cytokines [ Time Frame: 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.
  • Changes of High-Sensitivity C-Reactive Protein (hs-CRP) [ Time Frame: At Baseline and 12-week postintervention ]
    hs-CRP will be assessed using blood samples.
  • Changes of Adiponectin [ Time Frame: At Baseline and 12-week postintervention ]
    Adiponectin will be assessed using blood samples.
  • Physical Function [ Time Frame: 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).
  • Health-Related Quality of Life [ Time Frame: 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.
  • Prostate Cancer-Specific Quality of Life [ Time Frame: 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.
  • Fear of Cancer Progression [ Time Frame: 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.
  • Cancer Worry [ Time Frame: At baseline, 12-week (postintervention), 6-month, and 12-month ]
    Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.
  • General Anxiety [ Time Frame: 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.
  • Prostate Cancer-Specific Anxiety [ Time Frame: 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.
  • Depression [ Time Frame: At baseline, 12-week (postintervention), 6-month, and 12-month ]
    Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.
  • Perceived Stress [ Time Frame: At baseline, 12-week (postintervention), 6-month, and 12-month ]
    Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.
  • Self-esteem [ Time Frame: At baseline, 12-week (postintervention), 6-month, and 12-month ]
    Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.
  • Fatigue [ Time Frame: 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.
  • Physical Activity Level [ Time Frame: 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).
  • Exercise Motivation [ Time Frame: 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.
  • Body composition [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
  • Changes of Natural Killer (NK) cell counts [ Time Frame: At Baseline and 12-week postintervention ]
    We will assess the changes of the number of circulating NK cells from baseline to 12-week postintervention
  • Changes of White blood cell (WBC) [ Time Frame: At Baseline and 12-week postintervention ]
    We will assess the changes of the number of WBCs and differentials from baseline to 12-week postintervention
  • Changes of Prostate-Specific Antigen (PSA) [ Time Frame: At Baseline and 12-week postintervention ]
    We will assess the changes of PSA and %freePSA from baseline to 12-week postintervention
  • Changes of Insulin [ Time Frame: At Baseline and 12-week postintervention ]
    We will assess the changes in circulating insulin levels from baseline to 12-week postintervention
  • Changes of Glucose [ Time Frame: At Baseline and 12-week postintervention ]
    We will assess the changes in circulating glucose levels from baseline to 12-week postintervention.
  • Changes of Insulin-like Growth Factor (IGF)-axis [ Time Frame: At Baseline and 12-week postintervention ]
    We will assess the changes in circulating IGF-1 and IGF binding protein(IGFBP)-3 from baseline to 12-week postintervention.
  • Changes of Pro-Inflammatory Cytokines [ Time Frame: At Baseline and 12-week postintervention ]
    We will assess the changes in circulating pro-Inflammatory cytokines including IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, and IL-13 from baseline to 12-week postintervention.
  • Changes of Tumor Necrosis Factor (TNF)-α [ Time Frame: At Baseline and 12-week postintervention ]
    We will assess the changes in TNF-α from baseline to 12-week postintervention.
  • Changes of High-Sensitivity C-Reactive Protein (hs-CRP) [ Time Frame: At Baseline and 12-week postintervention ]
    We will assess the changes in hs-CRP from baseline to 12-week postintervention.
  • Cardiopulmonary Fitness [ Time Frame: At Baseline and 12-week postintervention ]
    VO2peak assessed by a treadmill exercise stress test
  • Physical Function [ Time Frame: At Baseline and 12-week postintervention ]
    Strength, flexibility, and agility assessed by the Senior's Fitness Test (SFT)
  • Health-Related Quality of Life [ Time Frame: At Baseline and 12-week postintervention ]
    European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire (EORTC-QLQ) - C30
  • Prostate Cancer-Specific Quality of Life [ Time Frame: At Baseline and 12-week postintervention ]
    Expanded Prostate Cancer Index Composite-26 (EPIC-26)
  • Fear of Cancer Progression [ Time Frame: At Baseline and 12-week postintervention ]
    Fear of Cancer Recurrence Inventory (FCRI)
  • Cancer Worry [ Time Frame: At Baseline and 12-week postintervention ]
    Cancer Worry Scale (CWS)
  • General Anxiety [ Time Frame: At Baseline and 12-week postintervention ]
    Anxiety (general): Spielberger State-Trait Anxiety Inventory (STAI)
  • Prostate Cancer-Specific Anxiety [ Time Frame: At Baseline and 12-week postintervention ]
    Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
  • Depression [ Time Frame: At Baseline and 12-week postintervention ]
    Epidemiologic Studies Depression Scale (CES-D)
  • Perceived Stress [ Time Frame: At Baseline and 12-week postintervention ]
    Perceived Stress Scale (PSS)
  • Self-esteem [ Time Frame: At Baseline and 12-week postintervention ]
    Rosenberg Self-Esteem Scale (RSES)
  • Fatigue [ Time Frame: At Baseline and 12-week postintervention ]
    Functional Assessment of Cancer Therapy- Fatigue (FACT-F)
  • Body composition [ Time Frame: At Baseline and 12-week postintervention ]
    Muscle mass, fat mass, and % body fat assessed by a bioelectrical impedance analyzer
  • Physical Activity Level [ Time Frame: At Baseline and 12-week postintervention ]
    Godin Leisure-Time Exercise Questionnaire (GLTEQ)
  • Exercise Motivation [ Time Frame: At Baseline and 12-week postintervention ]
    Theory of Planned Behaviour (TPB) constructs (instrumental and affective attitudes, subjective norms, intention and perceived behavioral control)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise During Active Surveillance for Prostate Cancer
Official Title  ICMJE A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance
Brief Summary 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.
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The outcome assessor will be blinded to group assignment for the primary outcome of natural killer cell cytotoxic activity and the secondary outcomes of other circulating biomarkers.
Primary Purpose: Supportive Care
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Behavioral: High-intensity aerobic interval training (HIIT)
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
Study Arms  ICMJE
  • Experimental: Exercise Group
    Supervised high-intensity aerobic interval training (HIIT) during active surveillance
    Intervention: Behavioral: High-intensity aerobic interval training (HIIT)
  • No Intervention: Usual Care Group
    The usual care group will be provided with standard active surveillance medical care.
Publications * Kang DW, Fairey AS, Boulé NG, Field CJ, Courneya KS. Exercise duRing Active Surveillance for prostatE cancer-the ERASE trial: a study protocol of a phase II randomised controlled trial. BMJ Open. 2019 Jul 4;9(7):e026438. doi: 10.1136/bmjopen-2018-026438.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 2, 2020)
52
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2017)
66
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03203460
Other Study ID Numbers  ICMJE HREBA.CC-17-0248
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kerry Courneya, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kerry S Courneya, PhD University of Alberta
PRS Account University of Alberta
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP