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

Launched by SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH · Mar 5, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring whether testosterone replacement therapy can help reduce cancer-related fatigue, improve sexual dysfunction, and enhance the overall quality of life in older men who have cancer and low testosterone levels. The study is specifically looking for men aged 55 and older who are currently receiving treatment for solid or blood cancers, or who have completed treatment within the last five years. Participants must also have low testosterone levels and report feeling fatigued.

If you qualify and choose to participate, you will be randomly assigned to receive either testosterone therapy or a placebo (a treatment that has no active ingredients). Throughout the trial, you will be monitored for changes in fatigue, sexual function, and quality of life. This study is important because fatigue is a common and challenging symptom for many cancer patients, and finding effective treatments can significantly improve their daily lives.

Gender

MALE

Eligibility criteria

• 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