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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00647075
First received: March 26, 2008
Last updated: December 14, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Dietary Supplement: Yunzhi extract
Dietary Supplement: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Yunzhi extract 3.5 g/day
 Dietary Supplement: Yunzhi extract
3.5 g/day
Placebo Comparator: 2
Placebo
 Dietary Supplement: Placebo
Placebo (starch)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647075

Contacts
Contact: Pere Gascon, MD +342275400 pgascon@clinic.ub.es

Locations
Spain
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
Investigators
Principal Investigator: Pere Gascon, MD Hospital Clinic
  More Information

No publications provided

Responsible Party: Vita Green Health Products Co. Ltd., Vita Green Europe, S.A.
ClinicalTrials.gov Identifier: NCT00647075     History of Changes
Other Study ID Numbers: YUNZHI-BC
Study First Received: March 26, 2008
Last Updated: December 14, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Clinic of Barcelona:
Breast cancer
undergoing
adjuvant/neoadjuvant chemotherapy
symptomatic therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013