Status:
COMPLETED
Clinical Trial of Trametes Versicolor in Women With Breast Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-75 years
Phase:
PHASE1
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 b...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00680667
Start Date
April 1 2007
End Date
April 1 2011
Last Update
November 29 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Bastyr University
Kenmore, Washington, United States