What types of exercise are most useful in reducing the side effects of hormonal therapy for prostate cancer

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12609000200280
• Date of registration: 21/04/2009
• Primary sponsor: University Edith Cowan University
• Public title: What types of exercise are most useful in reducing the side effects of hormonal therapy for prostate cancer
• Scientific title: A Phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer
• Date of first enrolment: 1/10/2008
• Target sample size: 195
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12609000200280.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Countries of recruitment

Australia

Contacts

• Name: Dr Daniel Galvao

• Name: Dr Daniel Galvao

Key inclusion & exclusion criteria

Inclusion criteria: Prostate cancer patients on androgen suppression (for>2 month) and who are anticipated to remain hypogonadal for the duration of the study (12 months).
Exclusion criteria: (1) metastatic bone disease, established osteoporosis or taking medications known to affect bone metabolism, such as bisphosphonates; (2) presence of musculoskeletal, neurological or cardiovascular disorder that could inhibit them from exercising (will required a GP consent); (3) participated in regular (e.g. 2 to 3 times per week) resistance training in the previous 3 months.

Age minimum: 0 No limit
Age maximum: 0 No limit
Gender: Males

Health Condition(s) or Problem(s) studied

prostate cancer

Intervention(s)

Resistance/impact loading exercise group (1): progressive supervised resistance (e.g. upper and lower body resistance based exercises using weight machines) and impact loading exercises (e.g. skipping, bounding and drop jumping) twice weekly 60 minutes sessions during 12 months.
Resistance/cardiovascular exercise group (2): progressive supervised resistance (e.g. upper and lower body resistance based exercises using weight machines) and aerobic exercises (e.g. walking and cycling) twice weekly 60 minutes sessions during 6 months.

Primary Outcome(s)

Cardiorespiratory capacity (maximum oxygen capacity) will be measured by expired air analysis during a staged walking test on a motorized treadmill. Exercise capacity (in METS) will be determined on the basis of the speed and grade of the treadmill as well as direct expired air gas analysis. Electrocardiogram will be recorded using a 12-lead monitoring system and blood pressure will be measured each testing minute by sphygmomanometer. This assessment will be conducted by medical doctor and an exercise physiologist.

Hip, spine and whole body bone mineral density (BMD). BMD (g/cm2) of the hip (total hip) and lumbar spine (L2-4) regions as well as whole body bone mineral content (BMC, g) will be assessed by dual-energy X-ray absorptiometry (DXA, Hologic Discovery A, Waltham, MA). Assessments will be conducted by an exercise physiologist with bone densitometry certification.

Secondary Outcome(s)

Balance and risk of falling: Neurocom Smart Balancemaster will be used to assess static and dynamic balance.

Blood biomarkers: Blood laboratory analysis including levels of testosterone, prostate specific antigen (PSA), insulin, lipid profile, glucose, HbA1c, alkaline phosphatase, Pro collagen Type 1 N-Terminal Propeptide (PINP), and C- reactive protein (CRP) levels will be measured commercially by an accredited Australian National

Blood pressure and Artery Stiffness. A validated oscillometric device (HEM-705CP, Omron Corporation, Japan) will be used to record brachial blood pressure at the dominant arm in triplicate. Central (ascending aortic) blood pressure and indices of arterial stiffness will be determined by pulse wave analysis using SphygmoCor version 6.1 software (AtCor Medical, Sydney, Australia). Radial artery pressure waveforms will be captured at the right arm by applanation tonometry using a high fidelity micromanometer (SPC-301, Millar Instruments, Houston, Texas, USA). A generalised transfer function is applied to the radial artery waveform in order to obtain the pressure waveform at the ascending aorta. This method has been validated against invasive techniques for determination of central blood pressure and the augmentation index (AIx) is a marker of systemic arterial stiffness. Assessments will be conducted by an exercise physiologist.

Body composition (lean and fat mass). Regional and whole body lean mass (including appendicular skeletal muscle mass) and fat mass will be derived from a DXA whole body scan. Assessments will be conducted by an exercise physiologist with bone densitometry operator certification.

Physical and muscle function: muscle strength and endurance, repeated chair rise, usual and fast walk, backward walk, stair clim, 400-m walk.

Quality of life: European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer ? Prostate Specific Module (EORTC QLQ-PR25), Medical Outcomes Study Short-Form 36 (SF-36), and The Brief Symptom Inventory-18 (BSI-18).

Secondary ID(s)

Nil

Source(s) of Monetary Support

National Health and Medical Research Council (NHMRC)

The Cancer Council of Queensland

Prostate Cancer Foundation of Australia (PCFA)

The Cancer Council of Western Australia

Secondary Sponsor(s)

Professor Robert Newton