Torkelson C.J., Sweet E., Martzen M.R. et al. Phase 1 Clinical Trial of Trametes versicolor in Women with Breast Cancer. ISRN Oncol. 2012;2012:251632.
Rationale
Before turkey tail could be tested as a breast-cancer adjunct, the basic dose-safety question needed an answer — this phase I escalation supplied it.
Methods
A two-center open-label phase I dose-escalation study: women who had completed chemotherapy and radiotherapy for breast cancer took encapsulated T. versicolor at 3, 6 or 9 g/day for six weeks (cohorts of 3). n=11 enrolled, n=9 completed; adverse events and immune markers (lymphocytes, NK activity) were tracked.
Results
Of nine adverse events, seven were mild, one moderate, one severe; the preparation was judged tolerable up to 9 g/day. Immune shifts were trends only: lymphocyte counts rose at 6–9 g and NK activity at 6 g/day.
Conclusions
Turkey tail is tolerable at up to 9 g/day in post-treatment breast-cancer patients — the safety ceiling that enabled later phase II work.
Worth noting
Read this card as the safety foundation for the turkey-tail oncology line: it defines the dose ceiling, nothing more. The immune trends are secondary observations, not results. Compare with the companion fotv-breast-cancer-2012 card — the same Torkelson phase I program reported from a different angle.