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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by:
Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE March 26, 2008
First Posted Date  ICMJE March 31, 2008
Last Update Posted Date December 15, 2010
Study Start Date  ICMJE November 2007
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2008)
Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yunzhi as Dietary Supplement in Breast Cancer
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Dietary Supplement: Yunzhi extract
    3.5 g/day
  • Dietary Supplement: Placebo
    Placebo (starch)
Study Arms  ICMJE
  • Experimental: 1
    Yunzhi extract 3.5 g/day
    Intervention: Dietary Supplement: Yunzhi extract
  • Placebo Comparator: 2
    Placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 28, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00647075
Other Study ID Numbers  ICMJE YUNZHI-BC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vita Green Health Products Co. Ltd., Vita Green Europe, S.A.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hospital Clinic of Barcelona
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pere Gascon, MD Hospital Clinic
PRS Account Hospital Clinic of Barcelona
Verification Date March 2010

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