NCT00680667

Clinical Trial of Trametes Versicolor in Women With Breast Cancer

Phase I Clinical Trial of Trametes Versicolor in Women With Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Coriolus versicolor extract	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.

Timeline

• Start date: 2007-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-05-20
• Last updated: 2017-11-29

Locations

2 sites across 1 country: United States