Patients were randomized to receive oral enobosarm at a dosage of 1 (n = 53) or 3 mg (n = 54) or placebo (n = 52) once daily for up to 113 days at centers in the United States or Argentina. The primary end point was defined as the change in total lean body mass from baseline as assessed by dual-energy X-ray absorptiometry (DEXA). After study termination, significant increases in total lean mass were noted in both enobosarm groups (enobosarm 1 mg: median 1.5 kg, range –2.1 to 12.6, P = .001 vs baseline, enobosarm 3 mg: 1.0 kg, –4.8 to 11.5, P = .046). The study drug was well

tolerated. POWER (Prevention and treatment Of muscle Wasting in patients with cancER) was a double-blind, randomized, placebo-controlled phase III trial of enobosarm 3 mg once daily that aimed to assess lean body mass and physical

function after treatment. Preliminary results were recently presented in abstract form. 75 A total Selleckchem Lumacaftor of 641 patients HIF-1�� pathway with stage 3 or 4 non–small cell lung cancer were randomized into 1 of 2 trials at initiation of first-line chemotherapy (platinum plus taxane or platinum plus nontaxane) plus add-on, consisting of either enobosarm or placebo for 5 months. The study’s coprimary end points, as assessed after 84 days of treatment, were physical function response assessed by stair-climb power and lean body mass as measured by DEXA. Compared with placebo, enobosarm treatment was associated with an increase in the stair-climb power and the lean body mass in the platinum plus taxane treatment arm, whereas in the platinum plus nontaxane arm, there was only a significant increase in the patients’ lean body mass (all P < .02). Using intramuscular testosterone replacement, Del Fabbro et al76 performed a randomized, double-blind, placebo-controlled trial in 29 patients with advanced cancer,

low bioavailable testosterone, and a fatigue score higher than 3 of 10 on the ESAS. Unfortunately, 4 weeks of treatment did not change patients’ FACIT score values in the testosterone group (n = 13, administered every 2 weeks) as compared with the placebo group (n = 16). Improvements were noted in the testosterone group with regard to the Sexual Desire Inventory score (P = .05) and the patients’ performance status (P = .02). The authors therefore concluded GNA12 that “four weeks of intramuscular testosterone replacement in hypogonadal male patients with advanced cancer did not significantly improve quality of life.” 76 Another novel anabolic agent has recently been tested in a randomized, double-blind, controlled trial. MT-102, also known as espindolol, is a novel anabolic/catabolic transforming agent that appears to possess 3 potential pharmacological targets in cancer cachexia: (1) reduced catabolism through nonselective β-blockade, (2) reduced fatigue and thermogenesis through central 5-HT1a antagonism, and (3) increased anabolism through partial β-2 receptor agonism.