Efficacy of Oral AHCC Supplementation in Female Breast Cancer Patients undergoing Anthracycline and Taxane based Adjuvant chemotherapy: Randomized, Double-blind, Placebo controlled, Phase-II Study
- Conditions
- Patients receiving adjuvant chemotherapy for breast cancer
- Registration Number
- JPRN-UMIN000015455
- Lead Sponsor
- PO Japanese Organisation for Research and Treatment of Cancer (JORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 50
Not provided
1. Previous chemotherapy which induce bone marrow suppression 2. Concurrent radiation or radiation within the past 4 weeks 3. Use of any mushroom based dietary supplement (7 day washout allowed) 4. Use of any other mixed herbal formula (nutritional multi vitamins are allowed) 5. Known allergy to any mushroom supplement or edible mushroom 6. Pregnant or lactating 7. Immunodeficiency disorder 8. Enrolled in other clinical trial 9. Cognitive impairment 10. Mental disorder 11. Communication difficulties due to anarthria 12. Inability to take oral medication 13. Malabsorption syndrome 14. Prior gastric resection 15. Active GI bleeding unrelated to cancer 16. The investigator's decision that a patient is inappropriate to enroll in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of grade 2 or higher adverse events by CTCAE v4.0 in WBC, neutrophil, Hb, Plt, T-Bil, ALP, AST, ALT, gamma-GTP, TG, Cre
- Secondary Outcome Measures
Name Time Method