Testosterone Treatment for Young Male Cancer Survivors
Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
Recruiting
Phase 2Interventional Study
Hypogonadism, MaleFatigue Syndrome, Chronic
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 54
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
240 (estimated)
Sponsor
Seattle Institute for Biomedical and Clinical Research · Other
Who this trial is looking for
This trial is looking for young men who are cancer survivors that have low testosterone and feel fatigued. Participants will take a testosterone drug to see if it helps improve their energy levels and overall quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I am a cancer survivor in remission for at least one year.
I am between 18 and 54 years old.
I report feeling fatigued.
I have low testosterone levels.
I have received chemotherapy or radiation therapy for my cancer.
I am willing to provide informed consent.
You may not be able to join if
I have hormone-dependent cancer.
I have had brain cancer.
I have taken anabolic agents in the past 6 months.
I have taken appetite stimulants in the past 6 months.
I have been on glucocorticoids for more than two weeks in the past 6 months.
I have uncontrolled congestive heart failure.
I have severe untreated sleep apnea.
I have had a heart attack or stroke in the past 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in yo…
The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.
Trial Locations
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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 ma…
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
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