Yunzhi as Dietary Supplement in Breast Cancer
YUNZHI-BC
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.
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 breast-cancer
Started Nov 2007
Typical duration for phase_4 breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 15, 2010
March 1, 2010
3.1 years
March 26, 2008
December 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)
6 months
Secondary Outcomes (1)
Treatment adherence Clinical and laboratory (including RBC, WBC and platelets) adverse events Adherence to chemotherapy schedule EPO and blood transfusion needs
6 months
Study Arms (2)
1
EXPERIMENTALYunzhi extract 3.5 g/day
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Women with diagnosis of breast cancer
- Undergoing adjuvant/neoadjuvant chemotherapy with either FEC, FAC, TAC, or EC + docetaxel combinations.
- ≥ 18 years of age
- Performance status: 0-2
- Ability to provide written informed consent
You may not qualify if:
- Any prior history of yunzhi use
- Use of other herbal remedies during the study duration
- 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
- Pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization)
- Systemic use of progestins, androgens or other steroids (dexamethasone is allowed if used as antiemetic therapy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Clinic
Barcelona, Barcelona, 08036, Spain
Hospital Parc Tauli
Sabadell, Barcelona, 08208, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pere Gascon, MD
Hospital Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 26, 2008
First Posted
March 31, 2008
Study Start
November 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
December 15, 2010
Record last verified: 2010-03