PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)

University of East Anglia50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Prostate Cancer

Interventions

Standard care plus exerciseOTHER

The exercise was supervised by exercise science staff in the exercise science facilities at the University of East Anglia, UK. Participants competed two weekly sessions for 12 weeks upon initiating ADT. Each session lasted \~60 min and included aerobic interval exercise on a cycle ergometer (Monark 824E; Varberg, Sweden) followed by resistance training. In addition to the supervised exercise sessions, patients were advised on how to increase their habitual physical activity levels and were encouraged to engage in 30 minutes of self-directed exercise on three days each week (e.g. brisk walking, cycling, home-based resistance training).

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male * 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)

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.

Time frame: Adjusted mean difference between groups at 3-month endpoint

Secondary Outcomes

Whole body fat mass (kg)

Time frame: Adjusted mean difference between groups at 6-month endpoint

Whole body fat-free mass (kg)

Whole body fat-free 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 method is highly valid for measuring changes in body composition (Savastano et al. 2010).