Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients
Condition: Advanced Cancer
MeSH terms: Neoplasms; Fatigue
Intervention: Testosterone; Placebo
Intervention description: Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.; Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Fatigue; Testosterone Replacement Therapy; Depo-Testosterone; Testosterone cypionate; Testosterone enanthate; Hypogonadic; Functional Assessment of Cancer Therapy-Fatigue subscale; FACIT-F

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male patients with any advanced cancer (metastatic or locally recurrent) who have a
             bioavailable testosterone (BT) of < 70 ng/dL.

          2. 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).

          3. 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.

          4. Participants must be willing to have blood samples drawn at screening and/or baseline
             and every two weeks until the end of treatment.

          5. 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.

          6. Eastern Cooperative Oncology Group (ECOG) PS </= 3 and participants must be able to
             stand up with or without assistance and to ambulate.

          7. 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.

        Exclusion Criteria:

          1. Patients who are determined incapable of completing questionnaires due to cognitive or
             physical deficits are ineligible for this study

          2. Abnormal Digital Rectal Exam (DRE) at baseline or history of severe untreated benign
             prostatic hypertrophy (BPH) with International Prostatic Symptom Score (IPSS) >19.

          3. Patients with a history of prostate cancer, a history of breast cancer or
             adenocarcinoma of unknown origin.

          4. A history of untreated obstructive sleep apnea.

          5. Uncontrolled severe heart failure (NYHA Class III or IV), uncontrolled cardiac
             arrhythmia or severe chronic obstructive pulmonary disease (COPD) requiring home
             oxygen.

          6. 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.

          7. Patients exhibiting clinically diagnosed severe dehydration are ineligible.

          8. Patients with a history of uncontrolled arrhythmia.

          9. Patients who are currently receiving androgen therapy or dehydroepiandrosterone (DHEA)

         10. 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%.

         11. Uncontrolled thyroid disease

         12. 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)

         13. Patients on warfarin, cyclosporine, dong quai, eucalyptus, dicumarol, germander, Jin
             bu huan, kava, pennyroyal, chaparral, comfrey, phenprocoumon are ineligible for this
             study.

         14. 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.

         15. 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.

         16. Patients who have a known sensitivity to sesame seed products.