Yunzhi as Dietary Supplement in Breast Cancer

Breast Cancer Clinical Trial

— YUNZHI-BC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00647075
• Other study ID #: YUNZHI-BC
• Status: Recruiting
• Phase: Phase 4
• First received: March 26, 2008
• Last updated: December 14, 2010
• Start date: November 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Hospital Clinic of Barcelona
• Contact: Pere Gascon, MD
• Phone: +342275400
• Email: pgascon[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• Yunzhi extract
3.5 g/day
• Placebo
Placebo (starch)

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Hospital Parc Tauli	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)		6 months	Yes
Secondary	Treatment adherence Clinical and laboratory (including RBC, WBC and platelets) adverse events Adherence to chemotherapy schedule EPO and blood transfusion needs		6 months	Yes