BACKGROUND: Uncontrolled studies show fatigue, anorexia, depression, and mortality are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary objective was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-Fatigue) at day 29. METHODS: This is a randomized, double-blinded placebo-controlled trial. Outpatients with advanced cancer, bioavailable testosterone (BT) <70 ng/dL and fatigue score >3/10 on the Edmonton Symptom Assessment Scale were eligible. Intra-muscular testosterone or sesameseed oil placebo was administered every 14 days to achieve BT levels 70-270 ng/dL. RESULTS: Sixteen placeboand 13 testosterone-treated subjects were evaluable. No statistically significant difference was found for FACIT-fatigue scores between arms (-2 ± 12 for placebo, 4 ± 8 for testosterone, p = 0.11). Sexual Desire Inventory score (p = 0.054) and performance status (p = 0.02) improved in the testosterone group. Fatigue subscale scores were significantly better (p = 0.03) in those treated with testosterone by day 72. CONCLUSIONS: Four weeks of intramuscular testosterone replacement in hypogonadal male patients with advanced cancer did not significantly improve quality of life. Larger studies of longer duration are warranted.
RCT Entities:
BACKGROUND: Uncontrolled studies show fatigue, anorexia, depression, and mortality are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary objective was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-Fatigue) at day 29. METHODS: This is a randomized, double-blinded placebo-controlled trial. Outpatients with advanced cancer, bioavailable testosterone (BT) <70 ng/dL and fatigue score >3/10 on the Edmonton Symptom Assessment Scale were eligible. Intra-muscular testosterone or sesame seed oil placebo was administered every 14 days to achieve BT levels 70-270 ng/dL. RESULTS: Sixteen placebo and 13 testosterone-treated subjects were evaluable. No statistically significant difference was found for FACIT-fatigue scores between arms (-2 ± 12 for placebo, 4 ± 8 for testosterone, p = 0.11). Sexual Desire Inventory score (p = 0.054) and performance status (p = 0.02) improved in the testosterone group. Fatigue subscale scores were significantly better (p = 0.03) in those treated with testosterone by day 72. CONCLUSIONS: Four weeks of intramuscular testosterone replacement in hypogonadal malepatients with advanced cancer did not significantly improve quality of life. Larger studies of longer duration are warranted.
Authors: Pedro Nazareth Aguiar Junior; Carmelia Maria Noia Barreto; Daniel de Iracema Gomes Cubero; Auro Del Giglio Journal: Support Care Cancer Date: 2019-07-13 Impact factor: 3.603
Authors: Samantha Huo; Anthony R Scialli; Sean McGarvey; Elizabeth Hill; Buğra Tügertimur; Alycia Hogenmiller; Alessandra I Hirsch; Adriane Fugh-Berman Journal: PLoS One Date: 2016-09-21 Impact factor: 3.240
Authors: D Tomlinson; P D Robinson; S Oberoi; D Cataudella; N Culos-Reed; H Davis; N Duong; F Gibson; M Götte; P Hinds; S L Nijhof; P van der Torre; S Cabral; L L Dupuis; L Sung Journal: Curr Oncol Date: 2018-04-30 Impact factor: 3.677
Authors: Domenico Fuoco; Jonathan di Tomasso; Caroline Boulos; Robert D Kilgour; Jose A Morais; Manuel Borod; Antonio Vigano Journal: Ecancermedicalscience Date: 2015-08-04