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

Torkelson CJ, Sweet E, Martzen MR, Sasagawa M, Wenner CA, Gay J, Putiri A, Standish LJ - ISRN Oncol (2012)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Family Medicine and Community Health, Medical School, University of Minnesota, 420 Delaware Street SE, MMC 381, Mayo Building B529, Minneapolis, MN 55455, USA.

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.

No MeSH data available.


Related in: MedlinePlus

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Mentions: Natural killer cell functional activity was dramatically reduced from pre- to post-RT for all 23 breast cancer patients who completed the first two visits of either the observational study (N = 14) or the dose escalation study (N = 9). Figure 3 shows that mean NK cell activity was 19.941 ± 18.959 before RT and decreased to 9.872 ± 13.454 after RT (N = 23). This decline was statistically significant (t(44) = 2.077, P = 0.043). A trend toward increased NK cell activity was observed in the 6 g Tv dose cohort.


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

Torkelson CJ, Sweet E, Martzen MR, Sasagawa M, Wenner CA, Gay J, Putiri A, Standish LJ - ISRN Oncol (2012)

© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3369477&req=5

Mentions: Natural killer cell functional activity was dramatically reduced from pre- to post-RT for all 23 breast cancer patients who completed the first two visits of either the observational study (N = 14) or the dose escalation study (N = 9). Figure 3 shows that mean NK cell activity was 19.941 ± 18.959 before RT and decreased to 9.872 ± 13.454 after RT (N = 23). This decline was statistically significant (t(44) = 2.077, P = 0.043). A trend toward increased NK cell activity was observed in the 6 g Tv dose cohort.

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Family Medicine and Community Health, Medical School, University of Minnesota, 420 Delaware Street SE, MMC 381, Mayo Building B529, Minneapolis, MN 55455, USA.

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.

No MeSH data available.


Related in: MedlinePlus