Men with advanced prostate cancer receiving androgen suppression therapy Cancer Malignant neoplasm of prostate
Conditions
Interventions
A 12 week pragmatic, combined exercise and diet advice intervention (a "lifestyle" intervention) compared with usual clinical care controls.
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed, non-localised prostate cancer (PCa) 2. Stable disease (stable prostate specific antigen [PSA]) 3. Receiving Androgen suppression therapy (AST) for a minimum period of six months 4. A willingness to comply with the randomised allocation to intervention and willing to undertake the requirements of the allocated intervention. If allocated to the exercise intervention, willing to aim to achieve 80% compliance to the exercise intervention.
Exclusion criteria
Exclusion criteria: 1. Participation in regular physical activity (defined as purposeful physical activity of a moderate intensity for 30 minutes three or more times per week in the previous six months) 2. Unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers 3. Uncontrolled painful or unstable bone lesions 4. Less than two months post surgical treatment 5. Any physical, neurological or psychiatric impairment or disease such as dementia, multiple sclerosis, severe arthritis or other condition that would limit the ability to understand and complete the study exercises and complete the required questionnaires, recall and record of dietary information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 12/07/2013: To be measured at baseline, 12 and 26 weeks: 1. Quality of life measured using the FACTP questionnaire 2. Diastolic blood pressure measured using an automated sphygmomanometer Previous primary outcome measures: 1. Exercise behaviour measured using the Godin Leisure Score Index questionnaire at baseline, 12 weeks and 6 months of follow-up 2. Dietary intake measured using three day diet diaries over the intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 12/07/2013: To be measured at baseline, 12 and 26 weeks: 1. Fatigue measured using the FACT-F questionnaire 2. Aerobic exercise tolerance measured using the Bruce treadmill protocol 3. Body mass measured using balance beam scales 4. Systolic blood pressure measured using an automated sphygmomanometer 5. Exercise behaviour measured using the Godin leisure score index questionnaire and heart rate monitoring To be measured at baseline and 12 weeks: 1. Dietary macro- and micro-nutrients measured using three-day diet diaries and Netwisp software 2. PSA measured using an immunoenzymatic assay 3. Serum lipid profile measured using an enzymatic colorimetric assay 4. Serum androgen profile measured using an electrochemiluminescence assay 5. Arterial health measured using flow-mediated dilatation Previous secondary outcome measures: 1. Quality of life measured using the FACT-P questionnaire 2. Fatigue measured using the FACT-F questionnaire 3. Body Mass Index (BMI) and waist-to-hip ratio 4. Aerobic exercise tolerance measured using the Bruce treadmill protocol 5. Lower limb strength measured using isokinetic dynamometry 6. Functional capacity measured using the chair sit-to-stand test Above outcomes measured at baseline, 12 weeks and at six months of follow-up. 7. Biomarkers associated with disease progression were assessed at baseline and after the intervention period. | — |
Countries
United Kingdom
Outcome results
None listed