Exercise During Active Surveillance for Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: High-intensity aerobic interval training (HIIT)

• Registration Number: NCT03203460
• Lead Sponsor: University of Alberta

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-06-29
• Study Start: 2018-07-01
• Primary Completion: 2020-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-11
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	High-intensity aerobic interval training (HIIT)	Supervised high-intensity aerobic interval training (HIIT) during active surveillance

Primary Outcome Measures

Name	Time	Method
Changes of Peak Oxygen Consumption (VO2peak)	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).

Secondary Outcome Measures

Name	Time	Method
Changes of High-Sensitivity C-Reactive Protein (hs-CRP)	At Baseline and 12-week postintervention	hs-CRP will be assessed using blood samples.
Changes of Adiponectin	At Baseline and 12-week postintervention	Adiponectin will be assessed using blood samples.
Changes of Insulin	At baseline and 12-week (postintervention)	Fasting insulin levels will be assessed using blood samples.
Changes of Fasting Glucose	At Baseline and 12-week postintervention	Fasting glucose levels will be assessed using blood samples.
Changes of Insulin-like Growth Factor (IGF)-axis	At baseline and 12-week (postintervention)	IGF-axis, including circulating IGF-1 and IGF binding protein(IGFBP)-3, will be assessed using blood samples.
Physical Function	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	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.
Depression	At baseline, 12-week (postintervention), 6-month, and 12-month	Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.
Fatigue	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.
Changes of Immune-Related Phenotype	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)	At baseline, 12-week (postintervention)	PSA will be assessed using blood samples.
Changes of Complete Blood Count with Differential (CBCD)	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 HbA1c	At Baseline and 12-week postintervention	HbA1c will be assessed using using blood samples.
Changes of Pro-Inflammatory Cytokines	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.
Fear of Cancer Progression	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.
General Anxiety	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.
Perceived Stress	At baseline, 12-week (postintervention), 6-month, and 12-month	Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.
Physical Activity Level	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).
Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts	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.
Cancer Worry	At baseline, 12-week (postintervention), 6-month, and 12-month	Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.
Prostate Cancer-Specific Anxiety	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.
Body composition	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.
Prostate Cancer-Specific Quality of Life	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.
Self-esteem	At baseline, 12-week (postintervention), 6-month, and 12-month	Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.
Exercise Motivation	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.

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada