Clinical Trial of Trametes Versicolor in Women With Breast Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00680667
Study type	Interventional
Source	Masonic Cancer Center, University of Minnesota
Contact
Status	Completed
Phase	Phase 1
Start date	April 2007
Completion date	April 2011

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.