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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00965341 |
Purpose
The goal of this clinical research study is to learn if and how testosterone replacement therapy may affect fatigue in males with advanced cancer and low testosterone levels.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: Testosterone Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Efficacy Study |
| Official Title: | A Preliminary Trial of Testosterone Replacement for Fatigue in Male Hypogonadic Patients With Advanced Cancer. |
| Estimated Enrollment: | 126 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Testosterone: Active Comparator |
Drug: Testosterone
Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
|
| Placebo: Placebo Comparator |
Drug: Placebo
Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Egidio Del Fabbro, MD | 713-792-3967 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Egidio Del Fabbro, MD | |
| The DeBakey VA Medical Center/Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Egidio Del Fabbro, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Egidio Del Fabbro, MD / Assistant Professor ) |
| Study ID Numbers: | 2008-0262 |
| Study First Received: | August 21, 2009 |
| Last Updated: | September 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00965341 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cancer Fatigue Testosterone Replacement Therapy Depo-Testosterone Testosterone cypionate |
Testosterone enanthate Hypogonadic Functional Assessment of Cancer Therapy-Fatigue subscale FACIT-F |
|
Fatigue Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Methyltestosterone Hormones Pharmacologic Actions |
Testosterone 17 beta-cypionate Signs and Symptoms Anabolic Agents Neoplasms Testosterone Therapeutic Uses Androgens |