Clinical Trial of Trametes Versicolor in Women With Breast Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Clinical Trial of Trametes Versicolor in Women With Breast Cancer|
- Maximum tolerated dose [ Time Frame: Up to 6 Weeks After Treatment ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: Over 6 Weeks ] [ Designated as safety issue: No ]as measured by the Functional Assessment of Cancer Therapy-for Patients With Breast, v4.0, questionnaire. The FACT-B is a 37-item quesionnaire using a 5-point Likert scale that evaluates physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns of breast cancer patients.
- Fatigue [ Time Frame: Over 6 Weeks ] [ Designated as safety issue: No ]as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue, v4.0, questionnaire. The FACIT-Fatigue is a 13 item fatigue scale collected at baseline, weekly and 6 weeks, and at the 3 week follow-up visit.
- Symptom Assessment [ Time Frame: Weekly and at 3 Week Follow-Up ] [ Designated as safety issue: Yes ]Toxicity will be assessed by the NCI CTCAE v3.0 (see Adverse Event section). The Symptom Assessment questionnaire is completed weekly during study and once at the 3-week follow-up visit
- NK cell activity [ Time Frame: Over 6 weeks ] [ Designated as safety issue: No ]Percent change in NK cell activity associated with coriolus versicolor extract
- comparison of immunologic measures [ Time Frame: Baseline and Post-Treatment ] [ Designated as safety issue: No ]
Will be performed by collecting peripheral blood at baseline, weeks 2,4,6 and 9 during study.
Preliminary data that compare baseline and post-treatment immunologic measures including natural killer cell activity, phagocytic index, T regulatory cell assay, T/B/NK cell population subset assays, and cytokine levels.
|Study Start Date:||April 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Trametes Versicolor
Females with Stage I-III infiltrating ductal adenocarcinoma of the breast being treated with Trametes versicolor capsules for 6 weeks after receiving radiation therapy.
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.
- 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.
- 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.
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Washington|
|Kenmore, Washington, United States|
|Principal Investigator:||Carolyn Torkelson, MD||Masonic Cancer Center, University of Minnesota|