Prostate Cancer
Conditions
Keywords
Prostate Cancer, Active Surveillance, Exercise, High-Intensity Interval Training, Randomized Controlled Trial
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).
Interventions
BEHAVIORALHigh-intensity aerobic interval training (HIIT)
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 HbA1c | At Baseline and 12-week postintervention | HbA1c will be assessed using 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. |
| 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. |
| Changes of High-Sensitivity C-Reactive Protein (hs-CRP) | At Baseline and 12-week postintervention | hs-CRP 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. |
| Changes of Adiponectin | At Baseline and 12-week postintervention | Adiponectin will be assessed using blood samples. |
| 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. |
| Cancer Worry | At baseline, 12-week (postintervention), 6-month, and 12-month | Cancer worry will be assessed using the Cancer Worry Scale (CWS) 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. |
| 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. |
| Depression | 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 | At baseline, 12-week (postintervention), 6-month, and 12-month | Perceived stress will be assessed using the Perceived Stress Scale (PSS) 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. |
| 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. |
| 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). |
| 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. |
| 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. |
Countries
Canada
Outcome results
None listed