Torkelson C.J., Sweet E., Martzen M.R., Sasagawa M., Wenner C.A., Gay J., Putiri A., Standish L.J. Phase 1 Clinical Trial of Trametes versicolor in Women with Breast Cancer. ISRN Oncology. 2012;2012:251632.
Rationale
Radiotherapy suppresses lymphocyte counts and NK-cell activity for months; turkey tail preparations are used adjunctively in Japan for exactly this recovery window. This phase I study asked the foundational questions: is it safe, does immune recovery differ by dose.
Methods
A two-center open-label phase I dose-escalation trial: 11 women with stage I–III breast cancer, post-radiotherapy, took T. versicolor mycelium (TV-M) at 3, 6 or 9 g/day for 6 weeks (some extended to 12). Immune subsets (CD3+, CD4+, NK cells), hematology and quality-of-life measures were tracked.
Results
Tolerability was confirmed up to 9 g/day — no dose-limiting toxicity. Immune markers (CD3+, CD4+ lymphocytes, NK-cell activity) recovered, with larger improvements at higher doses; quality-of-life measures improved.
Conclusions
Turkey tail mycelium was safe and well tolerated at up to 9 g/day, with dose-related immune-recovery trends — justifying the randomized phase II work that followed.
Worth noting
Phase I means small (n=11) and unblinded for efficacy — the real output is the safety ceiling and the dose-response hint. This study opened the formal clinical line for turkey tail in breast cancer; the PSK/PSP oncology dossier remains the strongest of any mushroom.