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| ID | Type | Description | Link |
|---|---|---|---|
| 14-0177 | Other Identifier | UNC IRB |
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We were not able to accrue any participants.
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This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy.
This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy. The investigators will also explore the effects of the exercise training on biomarkers of inflammation-hormonal status and their potential association with changes in lean mass and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention Arm | Experimental | The exercise intervention will consist of a combination of aerobic (cardiovascular exercise) and strength training (emphasis of the intervention) 3 times per week for 12 weeks with each session lasting ~1.5 hours. |
|
| Non-Exercise Control Arm | No Intervention | Participants in the Non-Exercise Control Arm will not exercise for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in lean mass between mCPRC patients undergoing a 12-week exercise intervention (intervention group) and mCPRC patients who do not undergo the exercise intervention (control group) | DEXA (Dual-energy X-ray absorptiometry) scans will measure lean mass at baseline and after the 12-week intervention. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Any condition that causes severe pain with exertion
History of bone fractures
Active cardiovascular disease including any of the following:
Acute or chronic respiratory disease
Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise
Neurological conditions that affect balance and, or muscle strength
Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Anthony C Hackney, Ph.D., D.Sc. | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| Lineberger Comprehensive Cancer Center website | View source |
| National Cancer Institute (NCI) website | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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