Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active 18 and over Other YUNZHI-BC NCT00647075

Trial Description

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 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Hospital Clinic de Barcelona

Pere Gascon, MD

Principal Investigator

Pere Gascon, MD		Ph: +342275400
		Email: pgascon@clinic.ub.es

Spain
	Barcelona
	Hospital Clinic de Barcelona
		Montse Muñoz, MD	Sub-Investigator
	Sabadell
	Hospital de Sabadell
		Miquel A Segui, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00647075
Information obtained from ClinicalTrials.gov on September 23, 2008