Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer
- Conditions
- Prostatic Neoplasm
- Interventions
- Other: Home-Based Exercise Program
- Registration Number
- NCT03397030
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 27
- Men aged 40 or older
- Ambulating male
- Diagnosed with low grade prostate cancer
- Subjects willing and able to provide consent to participating in the study Exclusion Criteria
- prostatectomy
- severe cardiac disease (New York Heart Association class III or greater)
- angina
- severe osteoporosis
- uncontrolled hypertension (blood pressure > 160/95mm Hg)
- uncontrolled sinus tachycardia (> 120 beats per minute)
- uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness,
- severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, lower limb fractures within 6 months, lower limb amputation).
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home-Based Exercise Program Home-Based Exercise Program 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.
- Primary Outcome Measures
Name Time Method Change in concentration of circulating Prognostic Biomarkers Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit. 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.
- Secondary Outcome Measures
Name Time Method Fatigue Biomarker Index Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit. 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)=\[GGHPPPP\]/\[ESPSLIA\]
Trial Locations
- Locations (2)
South Texas Veterans Health Care
🇺🇸San Antonio, Texas, United States
UT Health San Antonio School of Nursing
🇺🇸San Antonio, Texas, United States