Breast Cancer
Conditions
Keywords
Breast cancer, undergoing, adjuvant/neoadjuvant chemotherapy, symptomatic therapy
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.
Interventions
DIETARY_SUPPLEMENTYunzhi extract
3.5 g/day
DIETARY_SUPPLEMENTPlacebo
Placebo (starch)
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) | 6 months |
Secondary
| Measure | 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 |
Countries
Spain
Contacts
Primary ContactPere Gascon, MD
Outcome results
None listed