Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

Inclusion Criteria

• Male patients with any advanced cancer (metastatic or locally recurrent) who have a bioavailable testosterone (BT) 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 /= 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 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 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.