Yunzhi as Dietary Supplement in Breast Cancer (YUNZHI-BC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00647075
Recruitment Status : Unknown
Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : March 31, 2008
Last Update Posted : December 15, 2010
Information provided by:
Hospital Clinic of Barcelona

March 26, 2008
March 31, 2008
December 15, 2010
November 2007
December 2010   (Final data collection date for primary outcome measure)
Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00647075 on Archive Site
Treatment adherence Clinical and laboratory (including RBC, WBC and platelets) adverse events Adherence to chemotherapy schedule EPO and blood transfusion needs [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
Yunzhi as Dietary Supplement in Breast Cancer
A Randomized, Parallel, Double-blind, Placebo-controlled, Pilot Clinical Study on the Effects of Yunzhi as Dietary Supplement in 60 Adult Patients Undergoing Adjuvant/Neoadjuvant Chemotherapy for Breast Cancer.
The purpose of this study is to assess the effects of a dietary supplement, the traditional Asian mushroom Yunzhi, as adjuvant in the treatment of patients with breast cancer.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Dietary Supplement: Yunzhi extract
    3.5 g/day
  • Dietary Supplement: Placebo
    Placebo (starch)
  • Experimental: 1
    Yunzhi extract 3.5 g/day
    Intervention: Dietary Supplement: Yunzhi extract
  • Placebo Comparator: 2
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Women with diagnosis of breast cancer
  2. Undergoing adjuvant/neoadjuvant chemotherapy with either FEC, FAC, TAC, or EC + docetaxel combinations.
  3. ≥ 18 years of age
  4. Performance status: 0-2
  5. Ability to provide written informed consent

Exclusion Criteria:

  1. Any prior history of yunzhi use
  2. Use of other herbal remedies during the study duration
  3. Significant cardiac, pulmonary, renal, hepatic, gastrointestinal, CNS, psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the participant a poor candidate for study participation
  4. Pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization)
  5. Systemic use of progestins, androgens or other steroids (dexamethasone is allowed if used as antiemetic therapy)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Vita Green Health Products Co. Ltd., Vita Green Europe, S.A.
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Pere Gascon, MD Hospital Clinic
Hospital Clinic of Barcelona
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP