NCT03776045

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

Effects of Exercise in Prostate Cancer Patients Initiating Androgen Deprivation Therapy: A Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of East Anglia · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Standard care plus exercise	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).

Timeline

• Start date: 2013-08-12
• Primary completion: 2016-02-03
• Completion: 2016-02-03
• First posted: 2018-12-14
• Last updated: 2018-12-14