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The goal of this study is to demonstrate the impact of a home based exercise program versus wait-list control to modulate circulating prognostic biomarkers in men with prostate cancer under active surveillance.
Prostate cancer (PCa) is the most common non-skin cancer effecting American males. Several reports suggest that physical activity after cancer diagnosis is associated with better cancer- specific and overall survival in individuals diagnosed with PCa. There is a growing body of evidence for lifestyle interventions that aim to promote physical activity as having the potential to counter some of the adverse effects of cancer treatments, disease progression and other health outcomes. Exercise performed 2-3 times a week has been shown to improve physical fitness, functional performance, and quality of life in men with PCa; however, few men with PCa exercise regularly and do not meet national physical activity guidelines. A potential explanation on the lack of exercise in men with PCa is the absence of a structured, home-based, exercise program. While studies have shown positive effects of exercise in men with PCa, little is known about how physical activity effects tumor physiology in men with PCa. The primary objective of this pilot study is to gather preliminary data regarding the impact of a novel, home-based exercise program on PCa biomarkers associated with recurrence and metastasis of PCa in men under active surveillance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-Based Exercise Program | Experimental | Participants will complete a prescribed home-based exercise program and will follow up with research staff at the UT Health San Antonio School of Nursing. |
|
| Waitlist-Control Group | No Intervention | Participants assigned to this group will be asked to maintain normal activity and visit the UT Health San Antonio School of Nursing for research appointments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Based Exercise Program | Other | The intervention will include a combination of both aerobic and body-weight based exercises. The aerobic portion of the intervention will include 5 days of light to moderate intensity walking for 30 mins. Intensity will be set at 40-60% of the individual's heart rate reserve. The body-weight based exercises will be done 3 times a week and will consist of 3 sets of 15 reps of bodyweight squats, incline push-ups, and hip thrusts. If these exercises cannot be performed, lower intensity exercises such as sit-to-stand, wall push up and pelvic tilt can be replaced. Individuals in this group will be given a pocket guide with instructions on how to safely perform the exercises and document their completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of circulating Prognostic Biomarkers | Analyze concentrations of Prostate-specific antigen (PSA), Prostate-specific membrane antigen (PSMA), Early prostate cancer antigen (EPCA), Urokinase plasminogen activator (uPA), and Urokinase plasminogen activator receptor (uPAR) in serum collected at each visit with research staff. | Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Biomarker Index | Analyze a novel salivary biomarker for fatigue: Measurement of the salivary biomarker, the Fatigue Biomarker Index, will be measuring the concentration of each of two peptides, GGHPPPP (SEQ ID NO:1) and ESPSLIA (SEQ ID NO:2), in a saliva sample taken from the subject then calculating the ratio of the concentration of GGHPPPP (SEQ ID NO:1) to the concentration of ESPSLIA (SEQ ID NO:2) measured according to the equation: Fatigue biomarker index (FBI)=[GGHPPPP]/[ESPSLIA] |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Physical Function | A 6-minute walk will be will be completed by participants during their initial and last appointments with research staff. | Baseline and Week 24 visits. |
| Improvement in Body Composition |
Inclusion Criteria:
Participants are required to have prostate cancer under active surveillance.
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| Name | Affiliation | Role |
|---|---|---|
| Darpan Patel, PhD | UT Health San Antonio School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Veterans Health Care | San Antonio | Texas | 78229 | United States | ||
| UT Health San Antonio School of Nursing |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19949016 | Background | Galvao DA, Taaffe DR, Spry N, Joseph D, Newton RU. Combined resistance and aerobic exercise program reverses muscle loss in men undergoing androgen suppression therapy for prostate cancer without bone metastases: a randomized controlled trial. J Clin Oncol. 2010 Jan 10;28(2):340-7. doi: 10.1200/JCO.2009.23.2488. Epub 2009 Nov 30. | |
| 21640547 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2016 | Dec 21, 2017 | Prot_SAP_000.pdf |
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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 |
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This study is designed randomized controlled, 2 arm parallel group pilot study.
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No masking was used in this study.
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|
|
| Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit. |
Changes in participant's body composition will be measured at each visit with research staff.
| Baseline visit, Week 12 visit, Week 18 visit, and Week 24 visit. |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Keogh JW, MacLeod RD. Body composition, physical fitness, functional performance, quality of life, and fatigue benefits of exercise for prostate cancer patients: a systematic review. J Pain Symptom Manage. 2012 Jan;43(1):96-110. doi: 10.1016/j.jpainsymman.2011.03.006. Epub 2011 Jun 2. |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |