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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
56
Receive standard peri-operative care
Ancillary studies
Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively
Given IM
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
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.
Time frame: Baseline to 3 months
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.
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.
Major complications
Major complication considered Clavien-Dindo IIIb and above.
Time frame: Within 90 days of surgery
Minor complications
Minor complication considered Clavien-Dindo IIIb and below.
Time frame: Within 90 days of surgery
Rate of intensive care unit (ICU) admission
Admissions to the ICU between post-op day 1 to 90 days post surgery
Time frame: Up to 3 months post-surgery
Hospital length of stay
Number of days stayed in the hospital after surgery
Time frame: Up to 3 months post-operative
Discharge disposition
Determined by if patient is discharged to home, to home with services, or to facility.
Time frame: Discharge from hospital
Unplanned readmissions
Readmissions to hospital after discharge within 90 days
Time frame: Within 90 days of surgery
Mortality rate
Rate of patient deaths after surgery
Time frame: Within 90 days of surgery
Testosterone level
Levels of Testosterone determined by laboratory blood draw
Time frame: Up to 3 months post-operative
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