None listed
Conditions
Brief summary
The objective of this study is to a) determine the effects of androgen deprivation therapy (ADT) on the structure and function of the heart in prostate cancer patients and b) evaluate whether a targeted exercise intervention can reduce the ADT-induced impacts on the heart. Who is it for? You may be eligible to take part in the study if you are male aged 40 years and over, are diagnosed with prostate cancer and are currently receiving or scheduled to receive ADT (<1 month of initiating ADT) with or without upfront chemotherapy. You may also be able to take part if you are male and have not been diagnosed with cancer. Trial details: Participants in this study will be randomly (by chance) divided into two groups. Participants in one group (i.e. exercise intervention group) will attend a 3-month physical exercise intervention program that involves aerobic (e.g. cycling) and resistance exercise (i.e. lifting weights) undertaken 3 times per week at various community-based fitness centres/gyms throughout Melbourne. Exercise sessions will take approximately 60 minutes and will be conducted under the supervision of an accredited exercise physiologist. The usual care group will have no formalised exercise intervention during the three-month study period. During the research study period, the usual care participants will receive no formal advice from study investigators regarding physical activity. All participants will be offered an optional consultation with an exercise physiologist who will develop an individualised exercise program for each participant after completion of the three months follow up evaluation. All participants will be required to complete a number of tests at baseline and 3 months in order to assess the function and structure of their heart, their physical fitness, and body composition. All participants will be asked to complete an optional follow-up evaluation at 12-months. Participants will also be required to complete a number of questionnaires to assess their physical and psychological wellbeing.
Interventions
The 3-month periodised exercise intervention will involve three supervised exercise sessions per week. The exercise sessions will take approximately 30-60 minutes and will be supervised by an experienced exercise physiologist. Each participant will be asked to complete additional unsupervised exercise training (walking) for at least ~60 minutes per week to equate to the American College of Sports Medicine exercise and cancer roundtable recommendations of 150 minutes of aerobic exercise per week.
The 3-month periodised exercise intervention will involve three supervised exercise sessions per week. The exercise sessions will take approximately 30-60 minutes and will be supervised by an experienced exercise physiologist. Each participant will be asked to complete additional unsupervised exercise training (walking) for at least ~60 minutes per week to equate to the American College of Sports Medicine exercise and cancer roundtable recommendations of 150 minutes of aerobic exercise per week. The aerobic exercise training program will comprise of moderate intensity continuous training, moderately vigorous intensity interval training, and high intensity interval training each week and will follow an individualized training prescription based on participants’ baseline cardiopulmonary exercise test (CPET). The aerobic exercise training program will follow a athletic mesocycle approach; moderate continuous exercise training for month one and a combination of moderate intensity continuous training, moderately vigorous intensity interval training, and high intensity interval training for month two and three. Exercise intensity will be progressed each week by 7%-10%, depending on the baseline exercise capacity and training history of the participant. All participants will complete the aerobic exercise training on a cycle ergometer and/or treadmill. The resistance training program will be completed twice per week for 3 months. The progressive resistance training program will involve 5-6 exercises that target the major upper and lower body muscle groups. The initial intensity will be set to 60% of 1-RM (i.e. 60% of the maximal weight that can be lifted one time) at 3 sets of 12 repetitions. Exercise prescription will be progressive and modified according to individual response with the aim to increase the load and volume by 10% each week, in accordance with the American College of Sports Medicine guidelines for cancer survivors. Compliance and attendance (including the reason for any missed sessions) will be tracked throughout the program by the exercise physiologist.
Sponsors
Australian Catholic University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The inclusion criteria for the prostate cancer group are: • Histologically confirmed prostate cancer • 40 years and older • Currently receiving or scheduled to receive androgen deprivation therapy (<1 month of initiating therapy) with or without upfront chemotherapy Additionally, 10 aged-matched control participants will be recruited to assess the trajectory of change in cardiovascular function. Men will be included if they are male and have not been diagnosed with cancer.
Exclusion criteria
The exclusion criteria for the prostate cancer group and age-matched control are: • Unstable heart condition determined by study doctor and/or general practitioner • Previously received ADT or chemotherapy for the treatment of a previous cancer • Acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit exercise or put participants at risk during exercise testing • A contraindication to cardiac magnetic resonance imaging is a metallic implant or cardiac pacemaker
Outcome results
None listed