Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT00965341

Run by

M.D. Anderson Cancer Center

People needed

53

Starts

2009-09-01

Expected to finish

2012-09-01

Last updated by the study team

2016-09-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patients with any advanced cancer (metastatic or locally recurrent) who have a bioavailable testosterone (BT) of < 70 ng/dL.
• Male patients who have fatigue present every day for the last two weeks and have an Edmonton Symptom Assessment System (ESAS) fatigue score during the last 24 hours of >/= to 4 on a 0 to 10 scale (in which 0 = no fatigue and 10 = worst possible fatigue).
• Male patients who are willing to receive intramuscular injections every 2 weeks and are 18 years of age or older are eligible for this study.
• Participants must be willing to have blood samples drawn at screening and/or baseline and every two weeks until the end of treatment.
• Prostatic Specific Antigen (PSA) level must be lower than 4.0 ng/mL to be eligible for this study and Digital Rectal Exam (DRE) must be normal.
• Eastern Cooperative Oncology Group (ECOG) PS </= 3 and participants must be able to stand up with or without assistance and to ambulate.
• Hemoglobin (Hgb) >/= 9 g/dL. If the patient has not had blood drawn for a hemoglobin level in the past 28 days, one will be done to determine eligibility. Patients with a hemoglobin < 9 g/dL will be referred for treatment of their anemia.

You may not qualify if…

• Patients who are determined incapable of completing questionnaires due to cognitive or physical deficits are ineligible for this study
• Abnormal Digital Rectal Exam (DRE) at baseline or history of severe untreated benign prostatic hypertrophy (BPH) with International Prostatic Symptom Score (IPSS) >19.
• Patients with a history of prostate cancer, a history of breast cancer or adenocarcinoma of unknown origin.
• A history of untreated obstructive sleep apnea.
• Uncontrolled severe heart failure (NYHA Class III or IV), uncontrolled cardiac arrhythmia or severe chronic obstructive pulmonary disease (COPD) requiring home oxygen.
• Patients who have evidence of pre-existing hypopituitarism/hypogonadism including status post bilateral orchiectomy, for which replacement therapy is mandated, are ineligible for this study.
• Patients exhibiting clinically diagnosed severe dehydration are ineligible.
• Patients with a history of uncontrolled arrhythmia.
• Patients who are currently receiving androgen therapy or dehydroepiandrosterone (DHEA)
• Diabetics with a history of frequent episodes of hypoglycemia or uncontrolled diabetes mellitus (DM) defined as a fasting glucose over 200 mg/dL or HbA1c above 8%.
• Uncontrolled thyroid disease
• Hypercalcemia (corrected calcium > 10.5 g/dL); estimated glomerular filtration rate < 60 mg/min using the Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR); ALT > 3x the upper limit of normal (UNL)
• Patients on warfarin, cyclosporine, dong quai, eucalyptus, dicumarol, germander, Jin bu huan, kava, pennyroyal, chaparral, comfrey, phenprocoumon are ineligible for this study.
• Unstable symptoms could contribute to fatigue such as severe pain (score> 6 on ESAS) or severe depression (defined as a score of 15 or greater on the Depression Subscale of the Hospital Anxiety Depression Scale [HADS]). These symptoms should be resolved or stable for >/= 2 weeks at baseline for inclusion into study.
• Patients with hematocrit (Hct) > upper normal limits (UNL) will be excluded due to possible polycythemia. If the patient has not had blood drawn for a hematocrit level in the past 28 days, one will be performed at baseline to determine eligibility.
• Patients who have a known sensitivity to sesame seed products.

Where it is running

• The DeBakey VA Medical Center/Baylor College of Medicine — Houston, Texas, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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