Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
PRIMARY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (testosterone cypionate) Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months. |
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively
Drug: Testosterone Cypionate
Given IM
Other Names:
|
| Active Comparator: Arm II (best practice) Patients with normal testosterone levels receive standard peri-operative care. |
Other: Best Practice
Receive standard peri-operative care
Other Names:
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively
|
Outcome Measures
Primary Outcome Measures
- Changes in quality of life before and after surgery [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.
- Change in frailty phenotype before and after surgery [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.
- Major complications [Within 90 days of surgery]
Major complication considered Clavien-Dindo IIIb and above.
- Minor complications [Within 90 days of surgery]
Minor complication considered Clavien-Dindo IIIb and below.
- Rate of intensive care unit (ICU) admission [Up to 3 months post-surgery]
Admissions to the ICU between post-op day 1 to 90 days post surgery
- Hospital length of stay [Up to 3 months post-operative]
Number of days stayed in the hospital after surgery
- Discharge disposition [Discharge from hospital]
Determined by if patient is discharged to home, to home with services, or to facility.
- Unplanned readmissions [Within 90 days of surgery]
Readmissions to hospital after discharge within 90 days
- Mortality rate [Within 90 days of surgery]
Rate of patient deaths after surgery
- Testosterone level [Up to 3 months post-operative]
Levels of Testosterone determined by laboratory blood draw
Eligibility Criteria
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 who are undergoing chemotherapy and/or radiation therapy pre- or post-operatively
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Kenneth Ogan, MD, Emory University Hospital/Winship Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00001062
- NCI-2020-06998
- EU5097-20
- P30CA138292