NCT00647075UnknownPhase 4
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.
Hospital Clinic of Barcelona4 sites in 1 country60 target enrollmentStarted: November 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)
Time Frame: 6 months
Secondary Outcomes
- Treatment adherence Clinical and laboratory (including RBC, WBC and platelets) adverse events Adherence to chemotherapy schedule EPO and blood transfusion needs(6 months)
Investigators
Study Sites (4)
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