Testosterone therapy for older men with cancer-related fatigue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of testosterone replacement therapy in reducing cancer-related fatigue, improving sexual function, and enhancing quality of life in older men aged 55 and above who have solid or hematologic cancers and low testosterone levels. Participants will be randomly assigned to receive either testosterone gel or a placebo gel for six months, with multiple study visits to monitor progress. The study aims to provide insights into how testosterone therapy can alleviate symptoms associated with cancer treatment and androgen deficiency.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Georgia Cancer Center at Augusta University
  Augusta, Georgia, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Veterans Affairs Puget Sound Health Care System
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Jose Garcia, MD, Phd
• Email: jg77@uw.edu
• Phone: 206 764 2984

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.