Phase 1 Clinical Trial of Trametes versicolor in Women with Breast Cancer

Authors: Carolyn J. Torkelson, Erin Sweet, Mark R. Martzen, Masa Sasagawa, Cynthia A. Wenner, Juliette Gay, Amy Putiri, and Leanna J. Standish

Journal: ISRN Oncology

Study Design: Phase I, two-center, dose-escalation study

Participants: 11 women with breast cancer (9 completed the study)

Trial Length: 9 weeks (6 weeks of product use, 3-week washout)

Intervention:

• Oral Trametes versicolor (Tv) preparation in divided doses daily for 6 weeks. Trametes versicolor freezedried mycelial powder was obtained from Paul Stamets at Fungi Perfecti, Inc., Olympia, WA
  • 3 grams/day (cohort 1)
  • 6 grams/day (cohort 2)
  • 9 grams/day (cohort 3)

Primary Outcomes: Safety and tolerability of Tv

Secondary Outcomes: Immunological measures (complete blood count, NK cell activity, T regulatory cell assay, T/B/NK cell subset assay, phagocytic index, and cytokine levels)

Summary: The study evaluated the safety and tolerability of Tv in women with breast cancer after completing radiotherapy. The results showed that Tv was well-tolerated up to 9 grams/day, with only mild adverse events reported. The study also found trends towards improved immune function, including increased lymphocyte counts and NK cell activity, with higher doses of Tv. The findings suggest that Tv may be a safe and potentially beneficial adjuvant therapy for breast cancer patients after standard treatment.