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ISRN Oncology
Volume 2012 (2012), Article ID 251632, 7 pages
http://dx.doi.org/10.5402/2012/251632
Research Article

Phase 1 Clinical Trial of Trametes versicolor in Women with Breast Cancer

1Department of Family Medicine and Community Health, Medical School, University of Minnesota, 420 Delaware Street SE, MMC 381, Mayo Building B529, Minneapolis, MN 55455, USA
2Bastyr University Research Institute, Bastyr University, 14500 Juanita Drive N.E., Kenmore, WA 98028, USA

Received 10 January 2012; Accepted 16 February 2012

Academic Editors: C. Nicco and J. Nylandsted

Copyright © 2012 Carolyn J. Torkelson et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Introduction. Orally administered preparations from the Trametes versicolor (Tv) mushroom have been hypothesized to improve immune response in women with breast cancer after standard chemotherapy and radiotherapy. Methods. A phase I, two-center, dose escalation study was done to determine the maximum tolerated dose of a Tv preparation when taken daily in divided doses for 6 weeks after recent completion of radiotherapy. Eleven participants were recruited and nine women completed the study. Each cohort was comprised of three participants given one of three doses of Tv (3, 6, or 9 grams). Immune data was collected pre- and postradiation, at 3 on-treatment time points and after a 3-week washout. Results. Nine adverse events were reported (7 mild, 1 moderate, and 1 severe), suggesting that Tv was well tolerated. Immunological results indicated trends in (1) increased lymphocyte counts at 6 and 9 grams/day; (2) increased natural killer cell functional activity at 6 grams/day; (3) dose-related increases in CD8+ T cells and CD19+ B cells , but not CD4+ T cells or CD16+56+ NK cells. Conclusion. These findings show that up to 9 grams/day of a Tv preparation is safe and tolerable in women with breast cancer in the postprimary treatment setting. This Tv preparation may improve immune status in immunocompromised breast cancer patients following standard primary oncologic treatment.