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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: Yunzhi extract Dietary Supplement: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2007
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Yunzhi extract 3.5 g/day
Dietary Supplement: Yunzhi extract
3.5 g/day

Placebo Comparator: 2
Dietary Supplement: Placebo
Placebo (starch)

Primary Outcome Measures :
  1. Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00647075

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Contact: Pere Gascon, MD +342275400

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Hospital Parc Tauli Recruiting
Sabadell, Barcelona, Spain, 08208
Principal Investigator: Miquel A Segui, MD         
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Sub-Investigator: Montse Muñoz, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
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Principal Investigator: Pere Gascon, MD Hospital Clinic
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Responsible Party: Vita Green Health Products Co. Ltd., Vita Green Europe, S.A. Identifier: NCT00647075    
Other Study ID Numbers: YUNZHI-BC
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: December 15, 2010
Last Verified: March 2010
Keywords provided by Hospital Clinic of Barcelona:
Breast cancer
adjuvant/neoadjuvant chemotherapy
symptomatic therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases