This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Extracts of the medical mushroom Trametes versicolor (Tv) are prescribed as adjunctive immune therapy for women with breast cancer in both Asia and by licensed N. American naturopathic physicians. Japanese data suggest that Tv may improve survival and reduce recurrence in early stage breast cancer. While Tv is prescribed by NDs and other CAM practioners and used with growing frequency among breast cancer patients as an over-the-counter supplement there have yet to be well-designed clinical studies in the U.S. Standardized commercially available products are in wide use. The proposed phase I/II clinical trial of orally administered Tv will be the first U.S. trial of this promising CAM adjunctive immunomodulatory cancer therapy. Primary aims are: (1) to conduct an observational study (n=22) with estrogen receptor negative Stage 1 and IIa breast cancer patients in order to monitor and quantify the natural course of immune recovery and adverse events, as well as changes in fatigue and QOL scores, during the six weeks immediately following the completion of radiation therapy; (2) to determine the safety and tolerability of orally administered capsules of standardized Tv using a modified Fibonacci dose-escalation design (n=24) with doses ranging from 3000 mg-12,000 mg/day. The goal of the phase I trial is to determine the maximally tolerated dose. Secondary aims: (3) to gather preliminary data that compare baseline and post-treatment immunologic measures in up to a maximum of four Tv dose cohorts depending on the MTD: 3000 mg, 6000 mg, 9000 mg, and 12,000 mg/day oral doses of encapsulated standardized Tv; (4) to determine the feasibility of measuring changes in fatigue and quality of life changes associated with Tv administration in women with Stage I or IIa breast cancer who have recently completed chemotherapy and radiation therapy.
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