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| Name | Class |
|---|---|
| Sheffield Hallam University | OTHER |
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The proposed study will assess the feasibility of an exercise and dietary intervention in men with castrate resistant prostate cancer with secondary outcomes assessing improvements in physical functioning, fatigue, quality of life, and body composition.The study will have 2 arms, with one set of participants randomized to resistance exercise training intervention plus dietary advice and the other arm will be standard of care plus exercise advice.
Although there have been advances in recent years, therapeutic options remain limited for men with castrate resistant prostate cancer (CRPC). There is an unmet clinical need for interventions which can improve quality of life, functional capacity and cancer related fatigue. Adjunctive exercise therapy could be a potentially effective treatment for these men. A growing body of evidence has demonstrated numerous benefits in physiological and psychosocial outcomes in men with advanced prostate cancer. Further, there is observational evidence linking physical activity with reduced disease specific mortality after a diagnosis of cancer. Observational data also indicates that preserving skeletal muscle mass can improve responses to chemotherapy. The proposed study will assess the feasibility of an exercise and dietary intervention in men with castrate resistant prostate cancer with secondary outcomes assessing improvements in physical functioning, fatigue, quality of life, and body composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention arm | Experimental | exercise training intervention to include:
|
|
| standard of care arm | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | Various exercise tests |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants recruited who complete the intervention | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who show improvement in the Physical function assessments | 16 weeks | |
| number of participants who show improvement from treatment as shown by a DEXA scan | 16 weeks | |
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Inclusion Criteria:
Men with Castrate resistant prostate cancer
Men with histologically confirmed PCa on long-term ADT with either
Exclusion Criteria:
• Participation in other trials which might bias the evaluation of the primary objectives of the present study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Teaching Hospital NHS Foundation Trust | Sheffield | South Yorkshire | United Kingdom |
no plan to share data
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| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| standard of care |
| Other |
standard treatment |
|
| number of participants who show an increase in Muscle hypertrophy following intervention assessment |
| 16 weeks |
| number of participants who show increases in Muscle Strength following intervention assessment | 16 weeks |
| number of participants who show a higher score on Quality of life assessments following intervention | 16 weeks |
| number of participants who adhere to the Diet diaries | 16 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |