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

  • STATUS
    Recruiting
  • End date
    Dec 17, 2025
  • participants needed
    230
  • sponsor
    Seattle Institute for Biomedical and Clinical Research
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Updated on 17 March 2022
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Summary

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.

Description

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 55 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.

Details
Condition Hypogonadism, Male, Cancer, Fatigue
Treatment Placebo gel, testosterone 1.62% gel
Clinical Study IdentifierNCT04301765
SponsorSeattle Institute for Biomedical and Clinical Research
Last Modified on17 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Men with active lung or colorectal cancers who have received or are receiving chemoand /or radiation therapy. Patients who have no evidence of disease (NED) for 24 months or less, which means that they are <24 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 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
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
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