Clinical trial: Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone (NCT04049331)

Eligibility criteria:
Inclusion Criteria:

          -  Cancer survivors who have received chemotherapy and/or radiation therapy for their
             cancer and are now in remission for at least one year

          -  Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias

          -  Age: 18-50 years

          -  Serum testosterone, measured by mass spectrometry (gold standard method), of <348
             ng/dl and/or free testosterone <70 pg/ml. The lower limits of the normal range for
             total testosterone in healthy young men (age 19-40 years), is 348 ng/dL and the lower
             limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample97.
             Therefore, young symptomatic men with total testosterone <348 ng/dl could be
             considered testosterone deficient. As sex hormone binding globulin levels may be
             elevated in some men with cancer (resulting in elevation in total testosterone level),
             some of these symptomatic men may still be hypogonadal despite having total
             testosterone above this cut-off limit. However; their free testosterone levels may
             still be below the lower limit of normal. Thus, we will also include men with free
             testosterone <70 pg/mL.

          -  Self-reported fatigue. We have selected these symptoms because they are commonly
             reported in male cancer survivors. Fatigue will be defined as a score on Functional
             Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of <40, which best
             divides cancer patients from the general population with 84% accuracy96,185, and was
             used as the cut-off for the NIA-funded 50-million-dollar testosterone trial (The
             T-Trial).

          -  Ability and willingness to provide informed consent.

        Exclusion Criteria:

          -  Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown
             origin)

          -  Men with brain (potential cognitive impairment) and pancreatic cancers (short
             life-expectancy)

          -  Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within
             the past 6 months

          -  Appetite stimulating agents e.g. megestrol acetate within the past 6 months

          -  Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other
             glucocorticoids for more than two weeks in the past 6 months

          -  Baseline hematocrit >48%

          -  PSA >4 ng/ml in Caucasians; >3 ng/ml in African-Americans; nodule/induration on
             digital rectal exam

          -  Men with 1st order relatives with a history of prostate cancer

          -  Uncontrolled congestive heart failure

          -  Severe untreated sleep apnea

          -  Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke
             within 3 months

             o Previous stroke with residual cognitive or functional deficits; Mini-Mental State
             Examination score <24

          -  Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal

          -  Poorly controlled diabetes as defined by hemoglobin A1c >8.5%; Body mass index (BMI)
             >40 kg/m2

          -  Untreated unipolar depression (treated depression with medications or counseling will
             be allowed

          -  Bipolar disorder or schizophrenia
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? 0