Efficacy of Oral AHCC Supplementation in Female Breast Cancer Patients Undergoing Anthracycline-based Anticancer Drug as Adjuvant Chemotherapy: Randomized, Double-blind, Placebo controlled, Confirmatory Study
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000031386
- Lead Sponsor
- on-Profit Organization JORTC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 42
Not provided
1. Previous treatment with chemotherapy 2. Previous treatment with radiation simultaneously with chemotherapy or received <= 4 weeks prior to enrollment 3. Currently taking dietary supplements derived from basidiomycetes (such as agaricus or health food derived from a mushroom) (allowed if discontinued for more than 7 days before the start of the study) 4. Currently taking dietary supplements except for multivitamins (allowed if discontinued for more than 7 days before the start of the study) 5. Allergy for a health food derived from a mushroom or basidiomycetes 6. Pregnant or breastfeeding 7. Immune deficiency 8. Enrollment in other clinical trials 9. Cognitive disorder prior to enrollment 10. Psychiatric disorder that may affect data sampling 11. Unable to communicate verbally 12. Uncapable of oral ingestion 13. Malabsorption syndrome 14. Past history of gastrectomy 15. Active gastrointestinal bleeding unrelated with cancer 16. Investigator considers that the patient is not suitable for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The total number of doses of the G-CSF per the total number of completed course of the adjuvant chemotherapy
- Secondary Outcome Measures
Name Time Method 1) The total number of doses of the G-CSF for each course number of adjuvant chemotherapy 2) The number of doses of the G-CSF in each course of the adjuvant chemotherapy 3) Incidence rate of febrile neutropenia 4) Incidence rates of adverse events according to CTCAE v.4.0-JCOG of grade 1 or higher, grade 2 or higher 5) EORTC QLQ-C30 and EORTC QLQ-BR23 scores 6) Adherence to protocol (AHCC/placebo) 7) Completion rate of 4 courses of adjuvant chemotherapy and the proportion of completion without delay or dose reduction 8) Effect measurement based on RECIST v1.1 after the neoadjuvant chemotherapy