Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2007-11-30
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Yunzhi extract 3.5 g/day
Yunzhi extract
3.5 g/day
2
Placebo
Placebo
Placebo (starch)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Yunzhi extract
3.5 g/day
Placebo
Placebo (starch)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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)
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Clinic of Barcelona
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vita Green Europe, S.A.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pere Gascon, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clinic
Barcelona, Barcelona, Spain
Hospital Parc Tauli
Sabadell, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YUNZHI-BC
Identifier Type: -
Identifier Source: org_study_id