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

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.