Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

Launched by SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH · Aug 6, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating how a testosterone medication called Depo-Testosterone can help young male cancer survivors who are experiencing fatigue and have low testosterone levels. The study aims to determine if this treatment can improve their energy levels, sexual health, and overall quality of life. To participate, men aged 18 to 54 who have completed their cancer treatment and have been in remission for at least a year may be eligible, provided they have low testosterone levels and report significant fatigue.

Participants in the trial can expect to receive either the testosterone medication or a placebo (a non-active treatment) for comparison. The goal is to see if those receiving the testosterone experience more improvement in their fatigue than those receiving the placebo. It’s important to note that some men, particularly those with certain types of cancer or health conditions, may not be eligible to participate. If you're a cancer survivor feeling fatigued and think you might qualify, this could be an opportunity to help improve your well-being.

Gender

MALE

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: 18-54 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% accuracy, 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 cancer (potential cognitive impairment)
• • 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
• • 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) \>45 kg/m2
• • Untreated unipolar depression (treated depression with medications or counseling will be allowed
• • Bipolar disorder or schizophrenia