Yunzhi as Dietary Supplement in Breast Cancer | NCT00647075

Studies
Yunzhi as Dietary Supplement in Breast Cancer

NCT00647075

Sponsor

Hospital Clinic of Barcelona

Status

Unknown status

Last Update Posted

Dec 15, 2010Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Breast Cancer

Interventions

Yunzhi extract
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Mar 26, 2008

First Submission Date that Met QC Criteria

Mar 28, 2008

First Posted Date

Mar 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2010

Last Update Posted Date

Dec 15, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Yunzhi extract 3.5 g/day	Dietary Supplement: Yunzhi extract
2	Placebo Comparator	Placebo	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yunzhi extract	Dietary Supplement	3.5 g/day	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)		6 months

Secondary Outcomes

Measure	Description	Time Frame
Treatment adherence Clinical and laboratory (including RBC, WBC and platelets) adverse events Adherence to chemotherapy schedule EPO and blood transfusion needs		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pere Gascon, MD	Contact	+342275400		pgascon@clinic.ub.es

Overall Officials

Name	Affiliation	Role
Pere Gascon, MD	Hospital Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic	Recruiting	Barcelona	Barcelona	08036	Spain

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided