Effects of Exercise in Prostate Cancer Patients Initiating Androgen Deprivation Therapy: A Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University of East Anglia
- Enrollment
- 50
- Primary Endpoint
- Whole body fat mass (kg)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study evaluates whether exercise can reduce treatment-related adverse effects in prostate cancer patients initiating androgen deprivation therapy. Half of recruited participants completed a 3-month exercise intervention, while the other half did not perform any supervised exercise. It was anticipated that exercise would have a positive effect on body composition, cardiorespiratory fitness and quality of life.
Detailed Description
Androgen deprivation therapy (ADT) is routinely used as first-line treatment for locally advanced and metastatic prostate cancer. However, it is associated with many side effects such as increased fat mass and reduced skeletal muscle mass, cardiorespiratory fitness and metabolic health. Ultimately, these negative changes induced by ADT contribute to reduced health-related quality of life (HRQoL). This study evaluates whether 3-months of exercise can mitigate treatment toxicity in prostate cancer patients initiating ADT. In a parallel groups, prospective, randomised controlled design, participants were randomly allocated to a standard care control group or standard care plus exercise group. The exercise group completed 3-months of combined aerobic and resistance training. The standard care group did not receive any supervised exercise or specific physical activity recommendations. Outcomes were assessed at baseline, 3-month (post-intervention), and 6-month (follow-up) endpoints.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 50 to 80 years
- •Histologically confirmed stage I-IV prostate cancer
- •Scheduled for treatment with a luteinizing hormone-releasing hormone (LHRH) agonist either alone or combined with radiotherapy
- •Anticipated to remain on androgen deprivation therapy (ADT) for at least the next 6 months
- •Willing and able to give written informed consent.
- •Understand written and verbal instructions in English
- •World Health Organisation (WHO) performance status 0 to 1
Exclusion Criteria
- •Previously treated with ADT
- •Diagnosed or suspected metastatic bone disease
- •Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine (ACSM, 2010)
- •Prior myocardial infarction or heart failure
- •Chronic obstructive pulmonary disease (COPD)
- •Poorly controlled hypertension (≥ 200/110 mmHg)
- •Uncontrolled supraventricular tachycardia (≥ 100 bpm)
- •Pre-existing severe musculoskeletal, neurological or psychiatric condition that may affect their ability to complete the testing battery or exercise training, as determined by the patient's physician
- •Involvement in any other clinical trial or exercise trial
Outcomes
Primary Outcomes
Whole body fat mass (kg)
Time Frame: Adjusted mean difference between groups at 3-month endpoint
Whole body fat mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This was chosen as the primary outcome because adiposity has shown a high propensity to increase during the initial phases of androgen deprivation therapy, more so than other measures (Galvao et al. 2011), which highlights the importance of targeting body fat at this stage of treatment.
Secondary Outcomes
- Anthropometric measurements (cm)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Hand grip strength (kg)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire (version 4)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale (version 4)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Number of adverse events(Descriptive statistics reported during the 3-month intervention period)
- Whole body fat mass (kg)(Adjusted mean difference between groups at 6-month endpoint)
- Whole body fat-free mass (kg)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Oxygen pulse (ml/beat)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Oxygen uptake efficiency slope (OUES)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Concentration of triglycerides (mmol/L)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Ventilatory anaerobic threshold (ml/kg/min)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Peak oxygen consumption (VO2peak, ml/kg/min)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Ventilatory equivalents for O2 (V̇E/V̇O2) and CO2 (V̇E/V̇CO2)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Concentration of cholesterol (mmol/L)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Concentration of testosterone (nmol/L)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Concentration of sex hormone binding globulin (nmol/L)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- QRISK®2-2017 score(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Gleason score(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Skinfold thickness (mm)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Number of patients who were lost to follow-up(Descriptive statistics reported at 3-month and 6-month endpoints)
- Prostate specific antigen (ng/mL)(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Number of recruited participants(Descriptive statistics reported during the two-year recruitment period)
- Godin Leisure-Time Exercise questionnaire(Adjusted mean difference between groups at 3-month and 6-month endpoints)
- Attrition rate(Descriptive statistics reported during the 3-month intervention period.)
- Average number of exercise sessions completed(Descriptive statistics reported during the 3-month intervention period)