Yunzhi as Dietary Supplement in Breast Cancer - Full Text View

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 IV

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Dietary Supplements

ChemIDplus related topics:

Starch

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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.

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 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Yunzhi extract 3.5 g/day	Dietary Supplement: Yunzhi extract 3.5 g/day
2: Placebo Comparator 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

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

Contacts


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

Locations


Spain
	Hospital Clinic	Recruiting
	Barcelona, Spain, 08036
	Sub-Investigator: Montse Muñoz, MD

Spain, Barcelona
	Hospital Parc Tauli	Recruiting
	Sabadell, Barcelona, Spain, 08208
	Principal Investigator: Miquel A Segui, MD

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators


Principal Investigator:	Pere Gascon, MD	Hospital Clinic

More Information

Responsible Party:	Vita Green Europe, S.A. ( Vita Green Health Products Co. Ltd. )
Study ID Numbers:	YUNZHI-BC
First Received:	March 26, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00647075
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital Clinic of Barcelona:

Breast cancer

undergoing

adjuvant/neoadjuvant chemotherapy

symptomatic therapy

Study placed in the following topic categories:

Skin Diseases

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00647075