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NCT04301765

Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency

Active, Not Recruiting
PHASE2Ages 55+InterventionalSupportive care
Seattle Institute for Biomedical and Clinical Research
~230 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:testosterone 1.62% gelplacebo gel

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fatigue change
Measured over 6 months

Conditions

Hypogonadism, Male
Cancer
Fatigue

Explore related trials

Hematologic NeoplasmSolid NeoplasmTestosterone

Where it's being run

3 sites across 3 states
Georgia1
Massachusetts1
Washington1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Men with active solid or hematologic (blood) cancers who have received or are receiving chemo- and/or radiation therapy. Patients who have no evidence of disease (NED) for 60 months or less, which means that they are \<60 months from their last treatment (chemotherapy and/or radiation therapy) will be included.
Age: 55 years and older
Life expectancy of at least 6 months.
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 men is 348 ng/dL and the lower limits of free testosterone is \<70 pg/ml in the Framingham Heart Study sample. 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, but their free testosterone levels may still be below the lower limit of normal. Thus, men with free testosterone \<70 pg/mL will be included.
Fatigue. Fatigue was selected as it is a highly prevalent symptom in cancer patients. Fatigue will be defined as a score on FACIT-Fatigue subscale of \<40, which best divides cancer patients from the general population with accuracy.
Ability and willingness to provide informed consent

Exclusion

Men with current or prior history of prostate, breast, testicular, or adrenal cancers.
Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months
Hematocrit \>48%, serum creatinine \>2.5 mg/dL
PSA \>4 ng/ml; nodule or induration on digital rectal exam
Severe untreated sleep apnea
Uncontrolled congestive heart failure
Myocardial infarction, acute coronary syndrome, revascularization surgery, stroke or thromboembolism (of any etiology) within 6 months
Known history of thrombophilia due to a genetic mutation (e.g. Factor V Leiden)
Previous stroke with residual cognitive or functional deficits
Inability to provide informed consent; MMSE score \<24
Poorly controlled diabetes as defined by hemoglobin A1c \>10.0%
Body mass index (BMI) \>40 kg/m2
Bipolar disorder or schizophrenia

What this trial measures

  • Fatigue change6 months

    Primary outcome is change in fatigue score. Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-Fatigue)- The FACIT-Fatigue has been widely used in studies related to cancer-related fatigue and is able to detect clinically meaningful differences in fatigue scores in response to treatment. Population norms for the FACIT are also available, facilitating the interpretation of fatigue levels in patient populations. This instrument has been well-validated, is responsive to treatment and more sensitive to change in fatigue than other instruments. Score range: 0-52, the higher the score the better quality of life.