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Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Prostatic Neoplasm

Treatments

Other: Home-Based Exercise Program

Study type

Interventional

Funder types

Other

Identifiers

NCT03397030
HSC20160604HU

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Home-Based Exercise Program
Experimental group
Description:
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.
Treatment:
Other: Home-Based Exercise Program
Waitlist-Control Group
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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