Efficacy of AHCC in Breast Cancer Patients undergoing Anthracycline or Taxan-based Anticancer Drug
Phase 2
Recruiting
- Conditions
- Breast NeoplasmsBreast cancer, breast neoplasmsD001943
- Registration Number
- JPRN-jRCTs031180324
- Lead Sponsor
- Hamaguchi Reo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Agree to undergo adjuvant chemotherapy and plan to receive Doxorubicin/Cyclophosphamide (AC), Epirubicin/Cyclophosphamide (EC), 5-Fluorouracil/Epirubicin/Cyclophosphamide (FEC), Paclitaxel (PTX), nab-Paclitaxel (nab-PTX), Docetaxel (DTX), or Docetaxel/Cyclophosphamide (TC) therapy
Exclusion Criteria
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)
Currently taking dietary supplements except for multivitamins (allowed if discontinued for more than 7 days before the start of the study)
Allergy for a health food derived from a mushroom or basidiomycetes
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 chemotherapy
- Secondary Outcome Measures
Name Time Method The total number of doses of the G-CSF for each course number of the chemotherapy <br>The number of doses of the G-CSF in each course of the chemotherapy <br>Incidence rate of febrile neutropenia <br>Incidence rates of adverse events according to CTCAE v.4.0-JCOG of grade 1 or higher, grade 2 or higher<br>EORTC QLQ-C30 and EORTC QLQ-BR23 scores<br>Adherence to protocol (AHCC/placebo)<br>Completion rate of 4 courses of chemotherapy and the proportion of completion without delay or dose reduction <br>Efficacy assessment of neoadjuvant chemotherapy or metastatic/recurrent cases based on RECIST v1.1