Testosterone Replacement

Testosterone Replacement

PEP Topic 

Testosterone is an anabolic steroid hormone that is the primary sex hormone in males. Testosterone replacement is the provision of testosterone to the patient. Testosterone replacement has been studied in patients with cancer for treatment of hot flashes as well as other symptoms.

Effectiveness Not Established

Research Evidence Summaries

Del Fabbro, E., Garcia, J.M., Dev, R., Hui, D., Williams, J., Engineer, D., . . . Bruera, E. (2013). Testosterone replacement for fatigue in hypogonadal ambulatory males with advanced cancer: A preliminary double-blind placebo-controlled trial. Supportive Care in Cancer, 21, 2599-2607.

doi: 10.1007/s00520-013-1832-5

Study Purpose:

Primary Objective: To evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer using the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-Fatigue)
Secondary Objectives: To evaluate the effect of testosterone replacement therapy on additional symptoms associated with hypogonadism, including depression as measured by the Hospital Anxiety and Depression Scale (HADS); low sexual desire as measured by the Sexual Desire Inventory (SDI-2); and cachexia-related quality of life as measured by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) scale

Intervention Characteristics/Basic Study Process:

Gluteal injections of testosterone or placebo were administered at baseline, day 15, day 29, day 43, and day 57. Outcome measures were determined on day 29.

Sample Characteristics:

  • N = 29
  • MEAN AGE: 63 years for placebo group and 57 years for testosterone group
  • MALES: 100%
  • KEY DISEASE CHARACTERISTICS: Outpatient males with advanced cancer, bioavailable testosterone (BT) < 70 ng/dL, and fatigue scores > 3/10 on Edmonton Symptom Assessment Scale


  • SITE: Multi-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Texas VA Hospital and University Cancer Center

Phase of Care and Clinical Applications:

PHASE OF CARE: Transition phase after active treatment

APPLICATIONS: Elder care and palliative care

Study Design:

Randomized, double-blinded placebo-controlled trial

Measurement Instruments/Methods:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status
  • Edmonton Symptom Assessment Scale (ESAS)
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
  • Functional Assessment of Anorexia/Cachexia Therapy (FAACT)
  • Hospital Anxiety and Depression questionnaire (HADS)
  • Sexual Desire Inventory (SDI-2)
  • International Prostatic Symptom Score (IPSS)
  • Body composition by bioimpedence
  • Six-minute walk
  • Get-Up-and-Go test
  • Handgrip strength
  • Bioavailable testosterone


There were no statistically significant differences in FACIT-fatigue subscale or total scores; in testosterone levels between placebo and testosterone groups; and in the secondary outcome of anorexia/cachexia and sexual desire at day 29. ECOG-PS scores improved in the testosterone group, but the differences were not significant.


Testosterone replacements in hypogonadal male patients with advanced cancer did not significantly improve quality of life.


  • Small sample (< 30)
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Other limitations/explanation: Confounding variable of anemia; questionable use of bioimpedance as a measure of body composition; limited accrual; and limited length of intervention (4 weeks)

Nursing Implications:

This study did not demonstrate any benefit of testosterone replacement in this group of patients.