Clinical Trial of Trametes Versicolor in Women With Breast Cancer
NCT ID: NCT00680667
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2007-04-30
2011-04-30
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Estrogen and/or progesterone receptor-negative or positive
* Willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
* Willing to avoid taking any product containing Trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study.
* Adequate organ function within 14 days of study enrollment including the following:
* Adequate bone marrow reserve: White blood cells (WBC) ≥ 2,000/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL
* Hepatic: Bilirubin ≤ 20% times upper limit of normal (ULN), Alkaline phosphatase ≤ 20% times ULN, AST and ALT ≤ 20% times ULN
* Renal: Creatinine ≤ 20% times ULN
* Nutritional status: Albumin ≥ 3.0 g/dL
* Negative pregnancy test
* Voluntary written consent before performance of any study-related procedure not part of the normal medical care
Exclusion Criteria
* Known allergy to fungi, including mushrooms
* Serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study
* Receipt of hematopoietic growth factors (e.g., Neupogen™, Epogen™) within the previous 4 weeks
* Unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
* Unwilling to discontinue excluded medications and supplements
21 Years
75 Years
FEMALE
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Carolyn Torkelson, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Bastyr University
Kenmore, Washington, United States
Countries
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Other Identifiers
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UMN-0611M96168
Identifier Type: OTHER
Identifier Source: secondary_id
2007LS019
Identifier Type: -
Identifier Source: org_study_id