A phase I/II trial of a polysaccharide extract from Grifola frondosa (Maitake mushroom) in breast cancer patients: immunological effects

Authors: Gary Deng, Hong Lin, Andrew Seidman, Monica Fornier, Gabriella D’Andrea, Kathleen Wesa, Simon Yeung, Susanna Cunningham-Rundles, Andrew J. Vickers, Barrie Cassileth

Journal: Journal of Cancer Research and Clinical Oncology

Study Design: Phase I/II dose-escalation trial

Participants: 34 postmenopausal women with resected stage I, II, or III breast cancer, currently disease-free

Trial Length: 3 weeks

Intervention: Oral Maitake liquid extract at different dosages (0.1, 0.5, 1.5, 3, or 5 mg/kg) twice daily

Primary Outcomes: Safety and tolerability

Secondary Outcomes: Immunological parameters in peripheral bloodSummary: The study investigated the safety, tolerability, and immunological effects of Maitake extract in breast cancer survivors. The extract was well-tolerated, with only two patients experiencing mild side effects. The study found a significant association between Maitake dosage and immune response, with both immune-stimulatory and inhibitory effects observed depending on the specific parameter and dosage. The optimal dose varied for different immunological parameters, highlighting the complex immunomodulatory nature of Maitake extract. The clinical significance of these findings remains to be determined in future studies.