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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

Phase I dose escalation study protocol.
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Related In: Results  -  Collection


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fig1: Phase I dose escalation study protocol.

Mentions: The study duration was nine weeks and started after completion of radiation therapy. It included six weeks of product use followed by a three-week wash outperiod of no product use (Figure 1). Patients were screened and determined eligible for the study after completion of chemotherapy and prior to the initiation of radiation therapy. The study required six visits to the clinical research centers. The first study visit occurred prior to the initiation of radiation therapy, at which baseline labs were drawn. Within the first week following completion of radiation, participants had their second visit at which time labs were drawn, and the nine-week study was initiated. Six weeks of Tv product were provided for the participant, who returned to the research center for visit three, four, and five, two weeks apart for lab draw and assessment of product tolerability and adverse events. The final (sixth) visit was at nine weeks, following three weeks off product, for a final lab draw and assessment for any prolonged adverse events.


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)

Phase I dose escalation study protocol.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig1: Phase I dose escalation study protocol.
Mentions: The study duration was nine weeks and started after completion of radiation therapy. It included six weeks of product use followed by a three-week wash outperiod of no product use (Figure 1). Patients were screened and determined eligible for the study after completion of chemotherapy and prior to the initiation of radiation therapy. The study required six visits to the clinical research centers. The first study visit occurred prior to the initiation of radiation therapy, at which baseline labs were drawn. Within the first week following completion of radiation, participants had their second visit at which time labs were drawn, and the nine-week study was initiated. Six weeks of Tv product were provided for the participant, who returned to the research center for visit three, four, and five, two weeks apart for lab draw and assessment of product tolerability and adverse events. The final (sixth) visit was at nine weeks, following three weeks off product, for a final lab draw and assessment for any prolonged adverse events.

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