Elsevier

European Urology

Volume 65, Issue 5, May 2014, Pages 865-872
European Urology

Platinum Priority – Prostate Cancer
Editorial by Michael R. Harrison and Lee W. Jones on pp. 873–874 of this issue
Lifestyle Changes for Improving Disease-specific Quality of Life in Sedentary Men on Long-term Androgen-Deprivation Therapy for Advanced Prostate Cancer: A Randomised Controlled Trial

https://doi.org/10.1016/j.eururo.2013.09.040Get rights and content

Abstract

Background

Prostate cancer is a key driver of cancer-related global disability-adjusted life-years. Androgen-deprivation therapy (ADT) for advanced disease is linked to fatigue, reduced physical function, and quality of life (QoL).

Objective

To evaluate the effect of a lifestyle intervention on disease-specific QoL, diastolic blood pressure, and cancer-related fatigue in sedentary men receiving long-term ADT for advanced prostate cancer.

Design, setting, and participants

A total of 100 hundred sedentary men with locally advanced or metastatic prostate cancer on long-term ADT were randomised to an intervention or usual care group.

Intervention

A 12-wk lifestyle intervention consisting of aerobic and resistance exercise with parallel dietary advice.

Outcome measurements and statistical analysis

Disease-specific QoL was measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaires at 12 wk postintervention and at 6 mo following withdrawal of support. Analysis of covariance and mixed regression were conducted.

Results and limitations

Clinically relevant improvements in FACT-P were seen at 12 wk in the intervention group compared with controls (mean difference: 8.9 points; 95% confidence interval [CI], 3.7–14.2; adjusted p = 0.001). No difference was apparent at 6 mo (mean difference: 3.3 points; 95% CI, −2.6 to 9.3; adjusted p = 0.27). No difference in diastolic blood pressure was seen at either follow-up (all p > 0.05). Clinically relevant improvements in FACT-F were seen at 12 wk (mean difference: 5.3 points; 95% CI, 2.7–7.9; adjusted p < 0.001) and maintained following withdrawal of supervision (mean difference: 3.9 points; 95% CI, 1.1–6.8; adjusted p = 0.007). Improvements in exercise tolerance and behaviour were maintained at 6 mo (adjusted p < 0.001 and 0.038).

Conclusions

A lifestyle intervention resulted in a clinically meaningful improvement in disease-specific QoL that was not maintained postintervention. No effect on blood pressure occurred. Durability of response was seen in fatigue and exercise behaviour. Further evaluation of support structures is essential.

Trial registration

ISRCTN88605738.

Introduction

Prostate cancer has an impact on quality of life (QoL) through treatments for localised disease (such as erectile dysfunction, incontinence, and bowel dysfunction) and through direct symptoms from advanced or metastatic cancer. The mainstay of treatment of advanced prostate cancer is androgen-deprivation therapy (ADT) [1]. Indeed men might remain on ADT for up to two decades [2], [3], [4]. ADT comes with demonstrable adverse effects including increased fatigue [5], [6], psychological morbidity [7], reduced lean mass [8], physical function [9], and QoL [10], [11]. The presence of long-term comorbidities exacerbates reduced QoL in cancer survivors [12], and the reported increased risk of cardiovascular morbidity [13] potentially adds further burden to disease in men treated with ADT.

Current evidence supporting the use of exercise interventions for improving muscle function and QoL in men with prostate cancer has limited generalizability [14], [15], [16]. Crucially, no evidence has been presented to date from initially sedentary cohorts of men on long-term ADT or men with metastatic prostate cancer. There is little evidence to suggest what level of support is required to instigate and sustain lifestyle changes that result in clinically meaningful improvements in disease-specific QoL. In a preliminary study, we reported the feasibility of a tapered lifestyle intervention in men with prostate cancer on ADT [17]. We now report the results of a randomised controlled trial (RCT) designed to assess the effects of a tapered supervised exercise training programme with concurrent healthy eating advice (a lifestyle intervention) on improving and sustaining changes in disease-specific QoL, blood pressure, and fatigue in sedentary men on long-term ADT.

Section snippets

Study design

The study was a two-arm single-blind RCT design. Following local ethical approval, 100 men on ADT for locally advanced (n = 80) or metastatic (n = 20) prostate cancer were recruited via outpatient clinics. Eligible men were sedentary (ie, exercising < 90 min per week at a moderate intensity) and receiving continuous ADT for a minimum of 6 mo prior to recruitment, with planned long-term retention on ADT. Men with unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, and

Results

From 2008 to 2012, 100 men (mean age: 71 yr; range: 53–87 yr) were randomised to intervention (n = 50) and control (n = 50) groups: The mean duration of ADT was 33 and 30 mo, respectively (Table 1; Fig. 1). Attrition over the intervention period was comparable in both arms, with 85% of the cohort completing 12-wk follow-up and 68% of men attending follow-up at 6 mo. One man in the intervention arm developed atrial fibrillation, and there was one death in the usual care arm. There were no

Discussion

To date, this is the largest lifestyle intervention RCT of sedentary men with advanced prostate cancer on ADT that has included men with metastatic disease. We found that a combined tapered exercise and dietary advice intervention resulted in clinically important changes in disease-specific QoL [18] and fatigue [26]. When intervention support was withdrawn, we identified a loss of beneficial changes seen in QoL but maintenance of clinically relevant improvements in fatigue and exercise

Conclusions

To our knowledge this is the largest RCT of a lifestyle intervention in men on long-term ADT including those with metastatic disease. It reported clinically relevant changes in outcomes and what happened postintervention when support was removed. Beneficial effects on disease-specific QoL, exercise behaviour, aerobic exercise tolerance, fatigue, and dietary fat content are apparent with a supervised tapered intervention up to 12 wk. However, at 6 mo in the absence of support, improvements in

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