[#2009-05] A phase I/II trial of a polysaccharide extract from Maitake mushroom (Grifola frondosa) in breast cancer patients, Gary Deng et al.
A phase I/II trial of a polysaccharide extract from Maitake mushroom( Grifola frondosa) in breast cancer patients
Gary Deng · Hong Lin · Andrew Seidman · Monica Fornier · Gabriella D’Andrea · Kathleen Wesa · Simon Yeung · Susanna Cunningham-Rundles · Andrew J. Vickers · Barrie Cassileth
Abstract
Background: Cancer patients commonly use dietary supplements to “boost immune function”. A polysaccharide extract from Grifola frondosa (Maitake extract) showed immunomodulatory effects in preclinical studies and therefore the potential for clinical use. Whether oral administration in human produces measurable immunologic effects, however, is unknown.
Methods: In a phase I/II dose escalation trial, 34 postmenopausal breast cancer patients, free of disease after initial treatment, were enrolled sequentially in five cohorts. Maitake liquid extract was taken orally at 0.1, 0.5, 1.5, 3, or 5 mg/kg twice daily for 3 weeks. Peripheral blood was collected at days – 7, 0 (prior to the first dosing), 7, 14, and 21 for ex vivo analyses. The primary endpoints were safety and tolerability.
