Clinical trial NCT03397030: Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer
Official title: Impact of a Home-based Exercise Program on Prognostic Biomarkers in Men With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Keywords: Prostate Cancer
Biomarkers
Exercise
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 27
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed randomized controlled, 2 arm parallel group pilot study.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Primary outcomes:
measure: Change in concentration of circulating Prognostic Biomarkers
timeFrame: Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit.
Secondary outcomes:
measure: Fatigue Biomarker Index
timeFrame: Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit.
Other outcomes:
measure: Improvement in Physical Function
timeFrame: Baseline and Week 24 visits.
measure: Improvement in Body Composition
timeFrame: Baseline visit, Week 12 visit, Week 18 visit, and Week 24 visit.
Locations:
city: San Antonio
country: United States
facility: South Texas Veterans Health Care
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio School of Nursing
state: Texas
Study officials:
affiliation: UT Health San Antonio School of Nursing
name: Darpan Patel, PhD
role: PRINCIPAL_INVESTIGATOR
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