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

Trial Status: Active

This is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with incurable cancer who report fatigue and have low testosterone levels.

Inclusion Criteria

  • Men with active lung or colorectal cancers who have received or are receiving chemo- and/or radiation therapy
  • Age: 60 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 hormone-dependent cancers (breast, prostate)
  • Men with brain metastases from any type of cancer
  • Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months
  • Current use of systemic glucocorticoids (unless part of the chemotherapy regimen)
  • Appetite stimulating agents (e.g. megestrol acetate) within the past 1 month
  • Hematocrit >48%, serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal
  • PSA >4 ng/ml; nodule or induration on digital rectal exam
  • International Prostate Symptom Score (IPSS)>19
  • 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 >8.5%
  • Body mass index (BMI) >40 kg/m2
  • Untreated unipolar depression (treated depression is allowed)
  • Bipolar disorder or schizophrenia

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Egidio Del Fabbro
Phone: 804-628-0617

The overall objective is to conduct a double-blind, randomized, placebo-controlled, parallel

group trial to determine the efficacy of 6 months of physiological testosterone replacement

therapy in improving cancer related fatigue, sexual dysfunction, and body composition and

muscle function in men 60 years and older with active lung or colorectal cancers, who report

fatigue and have testosterone deficiency.There will be 5 study visits: 1) Screening, 2)

Baseline, 3) 2-Week Dose Adjustment Visit, 4) Three-month visit (Week 12), and 5) Six-month

visit. Testosterone or placebo gels will be applied by eligible trial participants at home;

participants will be trained on gel application procedures by research personnel.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Seattle Institute for Biomedical and Clinical Research

  • Primary ID AG061558
  • Secondary IDs NCI-2020-06783
  • Clinicaltrials.gov ID NCT04301765