Introduction: Cachexia associated with advanced cancer displays a variety of physical and psychological symptoms. Hypogonadism associated with cancer is reported to cause cachexia and these symptoms. The purpose of this study was to evaluate whether androgen replacement therapy can improve cancer-related symptoms in male advanced cancer patients.
Methods: An investigator-initiated, prospective, randomized controlled study was conducted in male advanced cancer patients. Patients with low serum testosterone levels were randomly assigned to the control group or the testosterone enanthate administration group (testosterone group). Differences in quality of life questionnaires and cachexia-related serum protein levels between groups were assessed to clarify whether testosterone enanthate can improve cachexia.
Results: In this study , 41 and 40 patients were randomized in the control and testosterone groups, respectively. Although no significant differences in the change of subscales and total scores in Functional Assessment of Anorexia/Cachexia Treatment were noted from the baseline between the two groups, the testosterone group showed a significantly better change in the “unhappiness” item of the Edmonton Symptom Assessment System at week 12 compared to baseline versus the control group (-1.4 and 0.0 points, respectively; mean, p = 0.007). The testosterone group significantly inhibited the change in serum tumor necrotic factor-a level at week 12 from the baseline compared with the control group (+0.4 and +0.1 pg/mL, respectively; mean, p = 0.005).
Conclusions: Testosterone enanthate did not improve most of the items in health-related quality of life questionnaires but significantly induced a better change in the “unhappiness” item of the health-related quality of life at week 12 compared with the control, associated with the inhibition of the deterioration of serum TNF-a levels in male advanced cancer patients.
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