Clinical Trial of Trametes Versicolor in Women With Breast Cancer

Phase I 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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Biological: Coriolus versicolor extract

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota
  • Washington
    • Kenmore, Washington, United States
      • Bastyr University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis, within the previous 12 months with Stage I-III, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy
• 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:

• Pregnant - Patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of Trametes versicolor.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: T. versicolor; Tv; turkey tail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose	Up to 6 Weeks After Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	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.	Over 6 Weeks
Fatigue	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.	Over 6 Weeks
Symptom Assessment	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	Weekly and at 3 Week Follow-Up
NK cell activity	Percent change in NK cell activity associated with coriolus versicolor extract	Over 6 weeks
comparison of immunologic measures	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.	Baseline and Post-Treatment

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Carolyn Torkelson, MD, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 18, 2008
• First Submitted That Met QC Criteria: May 18, 2008
• First Posted (Estimate): May 20, 2008

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage IIIB breast cancer; stage II breast cancer; stage IIIC breast cancer; stage I breast cancer; estrogen receptor-negative breast cancer; progesterone receptor-negative breast cancer; ductal breast carcinoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2007LS019; U19AT001998 (U.S. NIH Grant/Contract); UMN-0611M96168 (Other Identifier: IRB, University of Minnesota)