A Randomized, Placebo-Controlled, Multicenter Study of Ganoderma lucidum (W.Curt.:Fr.) Lloyd (Aphyllophoromycetideae) Polysaccharides (Ganopoly) in Patients with Advanced Lung Cancer

Preclinical studies have established that the polysaccharide fractions of Ganoderma lucidum (Ling Zhi, reishi mashroom) have potential antitumor activity. Recent clinical studies have demonstrated that G. lucidum polysaccharides enhanced host immune functions (e.g., enhanced natural killer cell activity) in patients with advanced solid tumor, although objective response was not observed. A randomized double-blind, placebo-controlled, multicenter clinical trial was conducted to evaluate the efficacy and safety of the G. lucidum polysaccharides, Ganopoly®, in patients with advanced lung cancer. Sixty-eight patients with histologically confirmed advanced lung cancer were enrolled. Eligibility criteria included con. rmation of diagnosis, objective measurable disease, a Karnofsky performance score і60, life expectancy of 12 weeks or greater, no recent or concomitant anticancer therapy, and informed consent. Patients were evaluated with respect to their extent of disease and quality of life (Karnofsky score), and hematologic and selected immunological and biochemical studies at baseline and after 12 weeks of treatment with oral Ganopoly or placebo at 600 mg three times daily. Patients in both groups were similar with respect to age, sex, treatment history, and lung tumor histology.