Status:
UNKNOWN
Yunzhi as Dietary Supplement in Breast Cancer
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00647075
Start Date
November 1 2007
End Date
December 1 2010
Last Update
December 15 2010
Active Locations (2)
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1
Hospital Clinic
Barcelona, Barcelona, Spain, 08036
2
Hospital Parc Tauli
Sabadell, Barcelona, Spain, 08208