Randomized Double-Blind Trial of XXXX Versus Placebo in Conjunction With Palliative Radiotherapy for @entity3478 .

@entity1 @entity3478 @entity5 @entity158 @entity4481 @entity9
PURPOSE: @entity3478 ( @entity3478 ) affects one third of @entity1 with @entity5 . Radiotherapy remains the gold-standard treatment; however, laboratory and clinical work suggest that @entity4481 may be useful in treating @entity3478 . The aim of this study was to examine @entity4481 in @entity1 with @entity3478 receiving radiotherapy. @entity1 AND METHODS: A multicenter, double-blind randomized trial of @entity4481 versus placebo was conducted. Eligible @entity1 were age >=  18 years, had radiologically proven bone metastases, were scheduled to receive radiotherapy, and had @entity158 scores >=  4 of 10 (on 0-to-10 numeric rating scale). Before radiotherapy, baseline assessments were completed, followed by random assignment. Doses of @entity4481 and placebo were increased over 4 weeks. The primary end point was treatment response, defined as a reduction of >=  2 points in worst @entity158 by week 4, accompanied by a stable or reduced opioid dose, compared with baseline. Secondary end points assessed average @entity158 , interference of @entity158 with activity, @entity158 , mood, quality of life, and adverse events. RESULTS: A total of 233 @entity1 were randomly assigned: 117 to placebo and 116 to @entity4481 . The most common @entity5 were prostate (n = 88; 38%), breast (n = 77; 33%), and lung (n = 42; 18%). In the @entity4481 arm, 45 @entity1 (38.8%) achieved the primary end point, compared with 47 (40.2%) in the placebo arm (adjusted odds ratio, 1.07; 95% CI, 0.63 to 1.81; P = .816). There were no statistically significant differences in average @entity158 , @entity158 interference, or quality of life between arms. There were differences in mood (P = .031) and @entity158 duration (P = .037) between arms. Outcomes were compared at 4 weeks. CONCLUSION: Our findings do not support the role of @entity4481 in @entity1 with @entity3478 receiving radiotherapy. The role of @entity4481 in @entity3478 with a clinical @entity9 component is unknown.
