Journal of Cancer Research and Clinical Oncology

, Volume 135, Issue 9, pp 1215–1221 | Cite as

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

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

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.

Keywords

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

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Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Gary Deng
    • 1
  • Hong Lin
    • 4
  • Andrew Seidman
    • 2
  • Monica Fornier
    • 2
  • Gabriella D’Andrea
    • 2
  • Kathleen Wesa
    • 1
  • Simon Yeung
    • 1
  • Susanna Cunningham-Rundles
    • 4
  • Andrew J. Vickers
    • 3
  • Barrie Cassileth
    • 1
  1. 1.Integrative Medicine Service, Department of MedicineMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  2. 2.Breast Cancer Medicine Service, Department of MedicineMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  3. 3.Department of Epidemiology and BiostatisticsMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  4. 4.The Cellular Immunology Laboratory, Department of PediatricsWeill Cornell Medical CollegeNew YorkUSA

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