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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731376
• Other study ID #: STUDY00001062
• Secondary ID: NCI-2020-06998EU
• Status: Recruiting
• Phase: Phase 1
• Start date: January 25, 2021
• Est. completion date: October 30, 2025

Study information

• Verified date: January 2024
• Source: Emory University
• Contact: Kenneth Ogan, MD
• Phone: 404-778-3038
• Email: kogan[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism
• Malignant Urinary System Neoplasm
• Neoplasms
• Urinary System Disorder
• Urinary System Neoplasm
• Urologic Diseases
• Urologic Neoplasms

Intervention

Other:
• Best Practice
Receive standard peri-operative care

Procedure:
• Quality-of-Life Assessment
Ancillary studies

Other:
• Questionnaire Administration
Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively

Drug:
• Testosterone Cypionate
Given IM

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 3 months
Primary	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.	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.
Primary	Major complications	Major complication considered Clavien-Dindo IIIb and above.	Within 90 days of surgery
Primary	Minor complications	Minor complication considered Clavien-Dindo IIIb and below.	Within 90 days of surgery
Primary	Rate of intensive care unit (ICU) admission	Admissions to the ICU between post-op day 1 to 90 days post surgery	Up to 3 months post-surgery
Primary	Hospital length of stay	Number of days stayed in the hospital after surgery	Up to 3 months post-operative
Primary	Discharge disposition	Determined by if patient is discharged to home, to home with services, or to facility.	Discharge from hospital
Primary	Unplanned readmissions	Readmissions to hospital after discharge within 90 days	Within 90 days of surgery
Primary	Mortality rate	Rate of patient deaths after surgery	Within 90 days of surgery
Primary	Testosterone level	Levels of Testosterone determined by laboratory blood draw	Up to 3 months post-operative