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Trial Title:
Yunzhi as Dietary Supplement in Breast Cancer
NCT ID:
NCT00647075
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
undergoing
adjuvant/neoadjuvant chemotherapy
symptomatic therapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Yunzhi extract
Description:
3.5 g/day
Arm group label:
1
Intervention type:
Dietary Supplement
Intervention name:
Placebo
Description:
Placebo (starch)
Arm group label:
2
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.
Criteria for eligibility:
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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Parc Tauli
Address:
City:
Sabadell
Zip:
08208
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Miquel A Segui, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Clinic
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Montse Muñoz, MD
Email:
Sub-Investigator
Start date:
November 2007
Completion date:
December 2010
Lead sponsor:
Agency:
Hospital Clinic of Barcelona
Agency class:
Other
Source:
Hospital Clinic of Barcelona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00647075
