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Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone

Primary Purpose

Hypogonadism, Malignant Urinary System Neoplasm, Urinary System Disorder

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Quality-of-Life Assessment
Questionnaire Administration
Testosterone Cypionate
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypogonadism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 who are undergoing chemotherapy and/or radiation therapy pre- or post-operatively
  • 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
  • Special populations: Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners

Sites / Locations

  • Emory University Hospital/Winship Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (testosterone cypionate)

Arm II (best practice)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in quality of life before and after surgery
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.
Change in frailty phenotype before and after surgery
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.
Major complications
Major complication considered Clavien-Dindo IIIb and above.
Minor complications
Minor complication considered Clavien-Dindo IIIb and below.
Rate of intensive care unit (ICU) admission
Admissions to the ICU between post-op day 1 to 90 days post surgery
Hospital length of stay
Number of days stayed in the hospital after surgery
Discharge disposition
Determined by if patient is discharged to home, to home with services, or to facility.
Unplanned readmissions
Readmissions to hospital after discharge within 90 days
Mortality rate
Rate of patient deaths after surgery
Testosterone level
Levels of Testosterone determined by laboratory blood draw

Secondary Outcome Measures

Full Information

First Posted
January 13, 2021
Last Updated
January 3, 2023
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04731376
Brief Title
Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
Official Title
Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Malignant Urinary System Neoplasm, Urinary System Disorder, Urinary System Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (testosterone cypionate)
Arm Type
Experimental
Arm Description
Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.
Arm Title
Arm II (best practice)
Arm Type
Active Comparator
Arm Description
Patients with normal testosterone levels receive standard peri-operative care.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard peri-operative care
Intervention Type
Procedure
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively
Intervention Type
Drug
Intervention Name(s)
Testosterone Cypionate
Other Intervention Name(s)
depAndro, Depo-Testosterone, Depotest, Depovirin, Pertestis, Virilon
Intervention Description
Given IM
Primary Outcome Measure Information:
Title
Changes in quality of life before and after surgery
Description
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.
Time Frame
Baseline to 3 months
Title
Change in frailty phenotype before and after surgery
Description
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.
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.
Title
Major complications
Description
Major complication considered Clavien-Dindo IIIb and above.
Time Frame
Within 90 days of surgery
Title
Minor complications
Description
Minor complication considered Clavien-Dindo IIIb and below.
Time Frame
Within 90 days of surgery
Title
Rate of intensive care unit (ICU) admission
Description
Admissions to the ICU between post-op day 1 to 90 days post surgery
Time Frame
Up to 3 months post-surgery
Title
Hospital length of stay
Description
Number of days stayed in the hospital after surgery
Time Frame
Up to 3 months post-operative
Title
Discharge disposition
Description
Determined by if patient is discharged to home, to home with services, or to facility.
Time Frame
Discharge from hospital
Title
Unplanned readmissions
Description
Readmissions to hospital after discharge within 90 days
Time Frame
Within 90 days of surgery
Title
Mortality rate
Description
Rate of patient deaths after surgery
Time Frame
Within 90 days of surgery
Title
Testosterone level
Description
Levels of Testosterone determined by laboratory blood draw
Time Frame
Up to 3 months post-operative

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Special populations: Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Ogan, MD
Phone
404-778-3038
Email
kogan@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Ogan, MD
Organizational Affiliation
Emory University Hospital/Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mersiha Torlak
Phone
404-778-4823
Email
mersiha.torlak@emory.edu
First Name & Middle Initial & Last Name & Degree
Kenneth Ogan, MD

12. IPD Sharing Statement

Learn more about this trial

Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone

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