None listed
Conditions
Brief summary
Aim? To determine whether exercise will result in favourable changes in gut microbial diversity, composition and metabolic profile of prostate cancer patients receiving androgen deprivation therapy (ADT). Who is it for? You may be eligible to join this study if you are a male aged 18 years or more and have histologically confirmed adenocarcinoma of the prostate, and currently receiving androgen deprivation therapy. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group receive a 12 week exercise intervention. The exercise intervention group will receive a 3-month, supervised, progressive and individually tailored exercise program involving resistance and aerobic exercises undertaken 3 times per week in an exercise clinic setting, supervised by an accredited exercise physiologist. Participants in the other group will receive usual care for the duration of the trial. Following the trial, the control group will be offered the same exercise program if the intervention to thank them for participation. All participants will complete assessments at baseline and after 12 weeks in order to evaluate gut health and function, diet and nutrition practices, muscle-bone health, adiposity, physical fitness, functional capacity, and psychosocial health. What will this research contribute? This novel study will provide preliminary information among a group of prostate cancer patients who are at risk of gut dysbiosis, and subsequently test whether exercise (a low-cost, readily-accessible therapy) can reduce the risk of gut dysbiosis, and/or reverse the side-effects of this health complication in men with prostate cancer receiving androgen deprivation therapy.
Interventions
Men with prostate cancer receiving androgen deprivation therapy will attend three clinic-based supervised exercise sessions each week, for 12 weeks (3 months), consisting of moderate-to-high intensity resistance and aerobic exercise (interval and continuous). Each session will take approximately 60 minutes, including warm-up and cool-down, and will be supervised by accredited exercise physiologists (AEP; Exercise and Sport Science Australia, Brisbane, Australia), face-to-face (in groups of up to 8 people per session). The exercise program is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance and retention, thus will be tailored, progressive, periodised and autoregulated in collaboration with the patient (i.e. adjusted based on the patient’s presentation at each session). Resistance exercise will be prescribed using repetition maximums (RM), where patients will be required to perform 6-8 different resistance exercises using major muscle groups, at 6-12 RM (the maximal weight that can be lifted 6 to 12 times each set, equivalent to ~60-85% of 1RM) for 3-4 sets per exercise to achieve moderate-to-high intensity and volume. Aerobic exercise will include 20 to 30 minutes of moderate-to-vigorous intensity activity (equating to ~60-85% of estimated maximum heart rate; or a rating of perceived exertion (RPE) between 6-9 using the BORG-10 scale) involving a variety of modes including walking, jogging, cycling or rowing, using treadmills and/or stationary ergometers respectively. Aerobic intensity will be monitored using heart rate monitors (Polar M400, H10 Sensor, Polar Electro, NSW, Australia) and an RPE chart for assessment. Patients will also be encouraged to perform additional aerobic exercise outside of their supervised exercise clinic visits, such as brisk walking, with the goal of achieving at least 150 minutes of moderate-to-vigorous intensity aerobic exercise each week (i.e. a further ~60-90 minutes self-managed). Flexibility exercises for all joints considered important for function and for all muscles engaged during the session will be provided during the cool-down phase of each exercise session. The exercise program will be periodised, progressive and autoregulated, to allow for transient changes in patient presentation to exercise sessions in accordance with their cancer therapy or treatment cycles. All exercise sessions will be fully supervised by an accredited exercise physiologist (AEP; Exercise and Sport Science Australia). All exercise sessions will take place at one of four exercise clinic locations: 1) Edith Cowan University (Joondalup), Vario Health Clinic; 2) Edith Cowan University (Mt Lawley), Gymnasium; 3) University of Western Australia; or 4) Fiona Stanley Hospital (Murdoch). Exercise program adherence and compliance will be assessed through the use of attendance rates to supervised clinic sessions; and percent of exercise session completed; specifically using exercise record sheets with prescribed programming variables; with actual versus completed components recorded.
Sponsors
Study design
Eligibility
Inclusion criteria
Men with localised or locally advanced prostate cancer, currently receiving androgen deprivation therapy (ADT) will be eligible to enrol into this study. Men must remain on ADT for the duration of their involvement in the study, and receive medical clearance to participate prior to enrolment. Age-matched, healthy male volunteers, with no previous or current cancer diagnosis, will be eligible to participate in this study, and will be recruited following the attainment of the two prostate cancer cohorts to ensure approximate balance for age. For inclusion, age-matched, healthy male volunteers will need to receive medical confirmation of their previous and current health status, with no evidence of current major musculoskeletal, cardiometabolic or neurological chronic disease or complications.
Exclusion criteria
Patients with visceral or bone metastases (i.e. advanced, or castrate-resistant prostate cancer); who have previously received chemotherapy; currently receiving radiation therapy; or who are currently on any experimental therapies will be excluded from this study. Further, men with any physical, mental or other contraindications that could interfere with exercise participation will be excluded. Lastly, men who cannot (or have difficulty) understanding English will also be excluded. Patients will also be excluded if: their treatment is for secondary cancer; medical records mention cognitive or learning problems; they have had any previous gastrointestinal surgery; and/or if they have taken antibiotics, prebiotics, probiotics, nutritional or ergogenic compliments during the 3 months prior to the study. Age-matched, healthy male volunteers will be excluded if they cannot provide medical confirmation of their previous / current health status; if they have any current major musculoskeletal, cardiometabolic or neurological chronic disease or complications; medical records mention cognitive or learning problems; they have had any previous gastrointestinal surgery; and/or if they have taken antibiotics, prebiotics, probiotics, nutritional or ergogenic compliments during the 3 months prior to the study.