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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.


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Mentions: We also measured the effects of radiotherapy and Tv administration on T, B, and NK cell populations in the nine patients who completed the phase I dose escalation study. From the WBC and flow cytometry immunophenotyping data, the absolute value (mm3) was calculated. Radiotherapy had an insignificant effect on CD4+ and CD8+ T cell, CD19+ B cell, and CD16+/56+ NK cell populations. Because immunophenotyping was not performed in the observational study, the numbers of composite (pre- and postradiation) scores were of those who participated in the dose escalation study (N = 9). The number of CD8+ T cells was not statistically different before and after the radiotherapy (Figure 4). However, increases in CD8+ T cells and CD19+ B cells were observed in peripheral blood for Tv supplementation groups. The CD8+ T cell counts over the 9-week dose escalation study were enhanced in the 9 gm Tv dose cohort compared to both the 3 g or 6 g group. One-way ANOVA was used to analyze the overall difference between dosage groups over the treatment period (2–4–6 weeks). It showed the statistically significant increase in the CD8+ cytotoxic T cells for the 9 g group compared to both the 3 g and 6 g group (F(2, 6) = 42.04, P = 0.0003). The difference between 3 g and 6 g groups was not significant (see Figure 4).


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: We also measured the effects of radiotherapy and Tv administration on T, B, and NK cell populations in the nine patients who completed the phase I dose escalation study. From the WBC and flow cytometry immunophenotyping data, the absolute value (mm3) was calculated. Radiotherapy had an insignificant effect on CD4+ and CD8+ T cell, CD19+ B cell, and CD16+/56+ NK cell populations. Because immunophenotyping was not performed in the observational study, the numbers of composite (pre- and postradiation) scores were of those who participated in the dose escalation study (N = 9). The number of CD8+ T cells was not statistically different before and after the radiotherapy (Figure 4). However, increases in CD8+ T cells and CD19+ B cells were observed in peripheral blood for Tv supplementation groups. The CD8+ T cell counts over the 9-week dose escalation study were enhanced in the 9 gm Tv dose cohort compared to both the 3 g or 6 g group. One-way ANOVA was used to analyze the overall difference between dosage groups over the treatment period (2–4–6 weeks). It showed the statistically significant increase in the CD8+ cytotoxic T cells for the 9 g group compared to both the 3 g and 6 g group (F(2, 6) = 42.04, P = 0.0003). The difference between 3 g and 6 g groups was not significant (see Figure 4).

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