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

Journal of Cancer Research and Clinical Oncology volume 135, pages 1215–1221 (2009)Cite this article

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.

Results

No dose-limiting toxicity was encountered. Two patients withdrew prior to completion of the study due to grade I possibly related side effects: nausea and joint swelling in one patient; rash and pruritus in the second. There was a statistically significant association between Maitake and immunologic function (p < 0.0005). Increasing doses of Maitake increased some immunologic parameters and depressed others; the dose–response curves for many endpoints were non-monotonic with intermediate doses having either immune enhancing or immune suppressant effects compared with both high and low doses.

Conclusions

Oral administration of a polysaccharide extract from Maitake mushroom is associated with both immunologically stimulatory and inhibitory measurable effects in peripheral blood. Cancer patients should be made aware of the fact that botanical agents produce more complex effects than assumed, and may depress as well as enhance immune function.

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Acknowledgments

We would like to thank Tina Chuck, Kristine Brown and Carrie Trevisan (Research Study Assistants) for their work in this study. The study was supported by the Memorial Sloan-Kettering Cancer Center Translational Research Grant and Grant Number P50 AT002779 from the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS).

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Authors and Affiliations

  1. Integrative Medicine Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1429 First Avenue, New York, NY, 10021, USA

    Gary Deng, Kathleen Wesa, Simon Yeung & Barrie Cassileth

  2. Breast Cancer Medicine Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, 10021, USA

    Andrew Seidman, Monica Fornier & Gabriella D’Andrea

  3. Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, 10021, USA

    Andrew J. Vickers

  4. The Cellular Immunology Laboratory, Department of Pediatrics, Weill Cornell Medical College, New York, NY, 10021, USA

    Hong Lin & Susanna Cunningham-Rundles

Authors
  1. Gary Deng
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  2. Hong Lin
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  3. Andrew Seidman
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  4. Monica Fornier
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  9. Andrew J. Vickers
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  10. Barrie Cassileth
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Correspondence to Gary Deng.

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Deng, G., Lin, H., Seidman, A. et al. A phase I/II trial of a polysaccharide extract from Grifola frondosa (Maitake mushroom) in breast cancer patients: immunological effects. J Cancer Res Clin Oncol 135, 1215–1221 (2009). https://doi.org/10.1007/s00432-009-0562-z

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  • DOI: https://doi.org/10.1007/s00432-009-0562-z

Keywords

  • Clinical trial
  • Breast cancer
  • Immunology
  • Maitake
  • Mushroom
  • Botanical
  • Herbal
  • Dietary supplement
  • Optimal dose
  • Complementary and alternative medicine