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Yunzhi as Dietary Supplement in Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast cancer, undergoing, adjuvant/neoadjuvant chemotherapy, symptomatic therapy
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Intervention
Name: Yunzhi extract
Type: Dietary Supplement
Name: Placebo
Type: Dietary Supplement
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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)
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)
Locations
Hospital Parc Tauli
Sabadell, Barcelona, Spain
Hospital Clinic
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Start Date
November 2007
Completion Date
December 2010
Sponsors
Hospital Clinic of Barcelona
Source
Hospital Clinic of Barcelona
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page