What is the clinical evidence from this study?

Study design: RCT. Population: Prostate cancer on long-term androgen deprivation therapy (ADT) (n=50). Intervention: Lifestyle intervention (supervised exercise training and dietary advice) vs. Usual care. Primary outcome: Endothelial function measured by brachial artery flow-mediated dilatation (FMD) expressed as the percentage change in arterial diameter at 12 weeks (Mean difference 2.2%, 95% CI 0.1-4.3, p=0.04).

January 14, 2016Open Access

Effects of a lifestyle intervention on endothelial function in men on long-term androgen deprivation therapy for prostate cancer

SGStephen GilbertThe University of Sydney GTGarry A. TewYork St John University CFCaroline FairhurstUniversity of York

Key Result

A 12-week lifestyle intervention of supervised exercise and dietary advice significantly improved endothelial function, increasing relative flow-mediated dilatation by 2.2% compared to usual care.

Study Design

Type

RCT (n=50)

Blinding

Single-blind

Randomization

1:1

Multicenter

Structured PICO

Does a 12-week lifestyle intervention improve endothelial function in men on long-term androgen deprivation therapy for prostate cancer?

Population

50 men (mean age 70.2 years) on long-term androgen deprivation therapy for prostate cancer were randomized to a 12-week lifestyle intervention or usual care and followed for 24 weeks.

Intervention

12-week lifestyle intervention including supervised exercise training and dietary advice

Comparator

Usual care

Outcome

Endothelial function measured by flow-mediated dilatation (FMD) of the brachial artery at 12 weekssurrogate

A 12-week lifestyle intervention comprising supervised exercise and dietary advice significantly improves endothelial function in men receiving long-term androgen deprivation therapy for prostate cancer.

Main Result

Mean Difference: 2.2 (95% CI 0.1–4.3)

Absolute Event Rate: 7.6% vs 5.3%

p-value: p=0.04

Limitations

Small sample size
Evidence of an increase in exercise behaviour and exercise tolerance in the control group
Improvements in outcome measures were lost following withdrawal of supervision at 24 weeks
Controlled recruitment excluded 67% of men identified as being treated with ADT, limiting generalisability

Abstract

BACKGROUND: Treatment of prostate cancer with androgen deprivation therapy (ADT) is associated with metabolic changes that have been linked to an increase in cardiovascular risk. METHODS: This randomised controlled trial investigated the effects of a 12-week lifestyle intervention that included supervised exercise training and dietary advice on markers of cardiovascular risk in 50 men on long-term ADT recruited to an on-going study investigating the effects of such a lifestyle intervention on quality of life. Participants were randomly allocated to receive the intervention or usual care. Cardiovascular outcomes included endothelial function (flow-mediated dilatation (FMD) of the brachial artery), blood pressure, body composition and serum lipids. Additional outcomes included treadmill walk time and exercise and dietary behaviours. Outcomes were assessed before randomisation (baseline), and 6, 12 and 24 weeks after randomisation. RESULTS: At 12 weeks, the difference in mean relative FMD was 2.2% (95% confidence interval (CI) 0.1-4.3, P=0.04) with an effect size of 0.60 (95% CI <0.01-1.18) favouring the intervention group. Improvements in skeletal muscle mass, treadmill walk time and exercise behaviour also occurred in the intervention group over that duration (P<0.05). At 24 weeks, only the difference in treadmill walk time was maintained. CONCLUSIONS: This study demonstrates that lifestyle changes can improve endothelial function in men on long-term ADT for prostate cancer. The implications for cardiovascular health need further investigation in larger studies over longer duration.

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