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Clinical Trials/NCT04731376
NCT04731376
Active, not recruiting
Phase 1

Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study

Emory University1 site in 1 country56 target enrollmentJanuary 25, 2021

Overview

Phase
Phase 1
Intervention
Quality-of-Life Assessment
Conditions
Hypogonadism
Sponsor
Emory University
Enrollment
56
Locations
1
Primary Endpoint
Unplanned readmissions
Status
Active, not recruiting
Last Updated
2 months ago

Overview

Brief Summary

This phase I trial investigates the safety of testosterone replacement therapy around the time of major urologic surgery (perioperative) in order to improve quality of life and post-operative outcomes such as decreased length of hospital stay, complications, and mortality in patients with low testosterone levels. Studies have demonstrated that patients undergoing testosterone replacement therapy have increased lean body mass, decreased fat mass and have improved physical function. Testosterone replacement therapy can also stimulate bone formation and may decrease the risk of fracture. Information from this trial may be used to support the incorporation of testosterone level testing and testosterone replacement into the perioperative treatment decision-making process.

Detailed Description

PRIMARY OBJECTIVE: I. To examine the safety and feasibility of perioperative testosterone replacement (TR) therapy in hypogonadal male patients undergoing major operations. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients with low testosterone levels receive testosterone cypionate intramuscularly (IM) once a week (QW) for 3 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients with normal testosterone levels receive standard peri-operative care.

Registry
clinicaltrials.gov
Start Date
January 25, 2021
End Date
December 31, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenneth Ogan

Principal Investigator

Emory University

Eligibility Criteria

Inclusion Criteria

  • Patients already scheduled for major surgery requiring an overnight hospital stay
  • Patients must be able to give informed consent
  • Patients must be willing to do study's preoperative and post-operative assessment tools

Exclusion Criteria

  • Patient with history of prostatectomy with detectable prostate specific antigen (PSA)
  • Patient with history of prostate radiation/chemotherapy treatment and has experienced bounce or rise in PSA
  • Patients with history of/undergoing orchiectomy
  • Patients undergoing hormone replacement therapy currently or history of testosterone use within last year
  • Patients who use anabolic steroids
  • Patients with history of solitary or undescended testis
  • Patients with history of pituitary disorders
  • Patients with history of thromboembolic events in last year
  • Patients with hematocrit \> 55%
  • Patients with uncontrolled congestive heart failure

Arms & Interventions

Arm I (testosterone cypionate)

Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.

Intervention: Quality-of-Life Assessment

Arm I (testosterone cypionate)

Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.

Intervention: Questionnaire Administration

Arm I (testosterone cypionate)

Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.

Intervention: Testosterone Cypionate

Arm II (best practice)

Patients with normal testosterone levels receive standard peri-operative care.

Intervention: Best Practice

Arm II (best practice)

Patients with normal testosterone levels receive standard peri-operative care.

Intervention: Quality-of-Life Assessment

Arm II (best practice)

Patients with normal testosterone levels receive standard peri-operative care.

Intervention: Questionnaire Administration

Outcomes

Primary Outcomes

Unplanned readmissions

Time Frame: Within 90 days of surgery

Readmissions to hospital after discharge within 90 days

Change in frailty phenotype before and after surgery

Time Frame: Baseline, post operative refers to the period after the procedure until final follow up and study completion. Will occur an average of 90 days after the procedure.

The Fried Frailty Criteria uses a comorbidity scale, measures of activity, physical tests of strength and speed, nutritional status and anatomic features to produce a score from 0-5. These numbers correspond with the following frailty categorizations: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5). This score represents one outcome measure.

Changes in quality of life before and after surgery

Time Frame: Baseline to 3 months

The Patient Reported Outcomes Measurement Information System (PROMIS Global Health-10) is a 10 question survey that uses questions concerning physical function, overall quality of life, physical health, mood, ability to participate in social roles and activities, pain and fatigue to arrive at a score between 10 and 50. Patient's score are the outcome we will measure.

Major complications

Time Frame: Within 90 days of surgery

Major complication considered Clavien-Dindo IIIb and above.

Mortality rate

Time Frame: Within 90 days of surgery

Rate of patient deaths after surgery

Minor complications

Time Frame: Within 90 days of surgery

Minor complication considered Clavien-Dindo IIIb and below.

Rate of intensive care unit (ICU) admission

Time Frame: Up to 3 months post-surgery

Admissions to the ICU between post-op day 1 to 90 days post surgery

Hospital length of stay

Time Frame: Up to 3 months post-operative

Number of days stayed in the hospital after surgery

Discharge disposition

Time Frame: Discharge from hospital

Determined by if patient is discharged to home, to home with services, or to facility.

Testosterone level

Time Frame: Up to 3 months post-operative

Levels of Testosterone determined by laboratory blood draw

Study Sites (1)

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