Clinical Trial of Trametes Versicolor in Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may
      be an effective treatment for breast cancer.

      PURPOSE: This phase I trial is studying the side effects and best dose of coriolus versicolor
      extract in treating women with stage I, stage II, or stage III breast cancer who have
      finished radiation therapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the maximum tolerated dose of oral coriolus versicolor extract in women
           with stage I-III, estrogen receptor- and/or progesterone receptor-negative or positive
           (as of 1/26/2009), infiltrating ductal adenocarcinoma of the breast who have recently
           completed standard post-surgery radiotherapy.

      Secondary

        -  To determine the feasibility of measuring changes in fatigue and quality of life of
           patients treated with this drug.

        -  To characterize the toxicity of this drug in these patients.

        -  To gather preliminary data that compare baseline and post-treatment immunologic
           measures, including differential blood counts (i.e., WBC), natural killer cell activity,
           phagocytic index, regulatory cell assay, T/B/NK cell population subset assays,
           peripheral blood mononuclear cell production of levels of interferon gamma, and tumor
           necrosis factor-alpha in these patients.

      OUTLINE: Patients receive oral coriolus versicolor extract twice daily for 6 weeks.

      Patients undergo quality of life and fatigue assessment at baseline, weekly during study, and
      at the 3-week follow-up visit.

      Blood samples are collected periodically for immunological marker studies. Samples are
      analyzed for T-regulatory cell, T-and B-lymphocyte, and NK cell activity in peripheral blood
      mononuclear cells (PBMC), phagocytic index in monocytes and granulocytes, and cytokine
      secretion and upregulation by flow cytometry, cytotoxicity assays, cytolysis assays,
      T-regulatory cell assay, or T/B/NK cell population subset assays. Changes in the production
      of tumor necrosis factor-alpha and interferon-gamma in serum and in supernatants of PBMCs are
      analyzed via standard enzyme-linked immunosorbent assay.

      After completion of study treatment, patients are followed at 3 weeks.
    

Intervention name(s): Coriolus versicolor extract
Intervention type(s): Biological
Intervention description(s): Trametes versicolor (Tv) capsules at the assigned dose level (3 grams/day up to 24 grams/day) twice a day every day and continuing for weeks.
Other intervention name(s): T. versicolor; Tv; turkey tail
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ductal breast carcinoma; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; estrogen receptor-negative breast cancer; progesterone receptor-negative breast cancer