Clinical Trial of Trametes Versicolor in Women With Breast Cancer

NCT00680667 | Completed Phase 1 DMC

• 3 other identifiers: 2007LS019U19AT001998UMN-0611M96168
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Keywords

ductal breast carcinoma; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; estrogen receptor-negative breast cancer; progesterone receptor-negative breast cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  Up to 6 Weeks After Treatment

Secondary Outcomes (5)

• Quality of life

  Over 6 Weeks

• Fatigue

  Over 6 Weeks

• Symptom Assessment

  Weekly and at 3 Week Follow-Up

• NK cell activity

  Over 6 weeks

• comparison of immunologic measures

  Baseline and Post-Treatment

Study Arms (1)

Trametes Versicolor

EXPERIMENTAL

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

Interventions

Coriolus versicolor extract BIOLOGICAL

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.

Also known as: T. versicolor, Tv, turkey tail

Trametes Versicolor

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Bastyr University

Kenmore, Washington, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast

Interventions

VPS Coriolus versicolor extract

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Carolyn Torkelson, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2008
• First Posted: May 20, 2008
• Study Start: April 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (2)