Yunzhi as Dietary Supplement in Breast Cancer (YUNZHI-BC)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Dietary Supplement: Yunzhi extract Dietary Supplement: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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. |
Study Start Date : | November 2007 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
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) |
- Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) [ Time Frame: 6 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647075
Contact: Pere Gascon, MD | +342275400 | pgascon@clinic.ub.es |
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 |
Principal Investigator: | Pere Gascon, MD | Hospital Clinic |
Responsible Party: | Vita Green Health Products Co. Ltd., Vita Green Europe, S.A. |
ClinicalTrials.gov Identifier: | NCT00647075 |
Other Study ID Numbers: |
YUNZHI-BC |
First Posted: | March 31, 2008 Key Record Dates |
Last Update Posted: | December 15, 2010 |
Last Verified: | March 2010 |
Breast cancer undergoing adjuvant/neoadjuvant chemotherapy symptomatic therapy |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |