The purpose of this multi-institutional, double-blind, randomized study was to assess the efficacy of dronabinol (Marinol^®, Unimed Pharmaceuticals, Deerfield, IL) administered either alone or in combination with megestrol acetate (Megase^®, Bristol-Myers Squibb Oncology, Princeton, NJ) in comparison to megestrol acetate for cancer-associated anorexia.