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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT00647075

First received: March 26, 2008

Last updated: December 14, 2010

Last verified: March 2010

History of Changes

Purpose

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	Intervention	Phase
Breast Cancer	Dietary Supplement: Yunzhi extract Dietary Supplement: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Dietary Supplements

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647075

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

No publications provided


Responsible Party:	Vita Green Health Products Co. Ltd., Vita Green Europe, S.A.
ClinicalTrials.gov Identifier:	NCT00647075 History of Changes
Other Study ID Numbers:	YUNZHI-BC
Study First Received:	March 26, 2008
Last Updated:	December 14, 2010
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital Clinic of Barcelona:


Breast cancer undergoing adjuvant/neoadjuvant chemotherapy symptomatic therapy

Additional relevant MeSH terms:


Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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