Back to resultsYunzhi as Dietary Supplement in Breast Cancer (YUNZHI-BC)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Yunzhi extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, undergoing, adjuvant/neoadjuvant chemotherapy, symptomatic therapy
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)
Sites / Locations
- Hospital Parc TauliRecruiting
- Hospital ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Yunzhi extract 3.5 g/day
Placebo
Outcomes
Primary Outcome Measures
Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)
Secondary Outcome Measures
Treatment adherence Clinical and laboratory (including RBC, WBC and platelets) adverse events Adherence to chemotherapy schedule EPO and blood transfusion needs
Full Information
NCT ID
NCT00647075
First Posted
March 26, 2008
Last Updated
December 14, 2010
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT00647075
Brief Title
Yunzhi as Dietary Supplement in Breast Cancer
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, undergoing, adjuvant/neoadjuvant chemotherapy, symptomatic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Yunzhi extract 3.5 g/day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Yunzhi extract
Intervention Description
3.5 g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (starch)
Primary Outcome Measure Information:
Title
Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pere Gascon, MD
Phone
+342275400
Email
pgascon@clinic.ub.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Gascon, MD
Organizational Affiliation
Hospital Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miquel A Segui, MD
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montse Muñoz, MD
12. IPD Sharing Statement
Learn more about this trial
Yunzhi as Dietary Supplement in Breast Cancer
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