Yunzhi as Dietary Supplement in Breast Cancer (YUNZHI-BC)

• ClinicalTrials.gov Identifier: NCT00647075
• Recruitment Status: Unknown
• First Posted: March 31, 2008
• Last Update Posted: December 15, 2010
• Sponsor: Hospital Clinic of Barcelona
• Information provided by: Hospital Clinic of Barcelona

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Dietary Supplement: Yunzhi extract; Dietary Supplement: Placebo	Phase 4

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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

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)

Contacts and Locations

Contacts

Contact: Pere Gascon, MD; +342275400; pgascon@clinic.ub.es

Locations

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

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

• Principal Investigator: Pere Gascon, MD; Hospital Clinic

More Information

• 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
• Last Update Posted: December 15, 2010
• Last Verified: March 2010

Keywords provided by Hospital Clinic of Barcelona:

Breast cancer; undergoing; adjuvant/neoadjuvant chemotherapy; symptomatic therapy

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases