Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
概览
- 阶段
- 1 期
- 干预措施
- Quality-of-Life Assessment
- 疾病 / 适应症
- Hypogonadism
- 发起方
- Emory University
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Unplanned readmissions
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (testosterone cypionate)
Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.
干预措施: Quality-of-Life Assessment
Arm I (testosterone cypionate)
Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.
干预措施: Questionnaire Administration
Arm I (testosterone cypionate)
Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.
干预措施: Testosterone Cypionate
Arm II (best practice)
Patients with normal testosterone levels receive standard peri-operative care.
干预措施: Best Practice
Arm II (best practice)
Patients with normal testosterone levels receive standard peri-operative care.
干预措施: Quality-of-Life Assessment
Arm II (best practice)
Patients with normal testosterone levels receive standard peri-operative care.
干预措施: Questionnaire Administration
结局指标
主要结局
Unplanned readmissions
时间窗: Within 90 days of surgery
Readmissions to hospital after discharge within 90 days
Change in frailty phenotype before and after surgery
时间窗: 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
时间窗: 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
时间窗: Within 90 days of surgery
Major complication considered Clavien-Dindo IIIb and above.
Mortality rate
时间窗: Within 90 days of surgery
Rate of patient deaths after surgery
Minor complications
时间窗: Within 90 days of surgery
Minor complication considered Clavien-Dindo IIIb and below.
Rate of intensive care unit (ICU) admission
时间窗: Up to 3 months post-surgery
Admissions to the ICU between post-op day 1 to 90 days post surgery
Hospital length of stay
时间窗: Up to 3 months post-operative
Number of days stayed in the hospital after surgery
Discharge disposition
时间窗: Discharge from hospital
Determined by if patient is discharged to home, to home with services, or to facility.
Testosterone level
时间窗: Up to 3 months post-operative
Levels of Testosterone determined by laboratory blood draw