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Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03397030
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Darpan Patel, The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Other: Home-Based Exercise Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is designed randomized controlled, 2 arm parallel group pilot study.
Masking: None (Open Label)
Masking Description: No masking was used in this study.
Primary Purpose: Treatment
Official Title: Impact of a Home-based Exercise Program on Prognostic Biomarkers in Men With Prostate Cancer
Actual Study Start Date : January 5, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Home-Based Exercise Program
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.
Other Name: Exercise Group

No Intervention: Waitlist-Control Group
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.



Primary Outcome Measures :
  1. Change in concentration of circulating Prognostic Biomarkers [ Time Frame: 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 :
  1. Fatigue Biomarker Index [ Time Frame: 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]


Other Outcome Measures:
  1. Improvement in Physical Function [ Time Frame: Baseline and Week 24 visits. ]
    A 6-minute walk will be will be completed by participants during their initial and last appointments with research staff.

  2. Improvement in Body Composition [ Time Frame: 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants are required to have prostate cancer under active surveillance.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men aged 40 or older
  • Diagnosed with prostate cancer
  • Under active surveillance
  • Subjects willing and able to provide consent to participating in the study

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397030


Contacts
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Contact: Darpan Patel, PhD 210-567-0362 pateld7@uthscsa.edu

Locations
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United States, Texas
UT Health San Antonio School of Nursing Recruiting
San Antonio, Texas, United States, 78229
Contact: Darpan Patel, PhD    210-567-0362    pateld7@uthscsa.edu   
Principal Investigator: Darpan I Patel, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Darpan Patel, PhD UT Health San Antonio School of Nursing
  Study Documents (Full-Text)

Documents provided by Darpan Patel, The University of Texas Health Science Center at San Antonio:

Publications:

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Responsible Party: Darpan Patel, PhD, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03397030     History of Changes
Other Study ID Numbers: HSC20160604HU
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Darpan Patel, The University of Texas Health Science Center at San Antonio:
Prostate Cancer
Biomarkers
Exercise

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases