Breast cancer
Conditions
Interventions
To be taken 2 capsules of AHCC (0.5 g) three times a day after meals (6 capsules in total, 3.0 g/day) from the start of the adjuvant chemotherapy.
To be taken 2 capsules of placebo (0.5 g) three times
Sponsors
Non-Profit Organization JORTC
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Understanding of the nature and consequences of the study and voluntary signature of the informed consent document 2. Female of age >= 20 and < 70 years at the time of consent 3. Histologically confirmed breast cancer 4. Agree to undergo adjuvant chemotherapy and plan to receive Doxorubicin/Cyclophosphamide (AC), Epirubicin/Cyclophosphamide (EC), or 5-Fluorouracil/Epirubicin/Cyclophosphamide (FEC) therapy 5. Eastern Cooperative Oncology Group Performance Status <= 1 6. Laboratory findings within the following ranges (at <= 14 days prior to enrollment); (1) Leukocytes >= 3,000/mm3 (2) Neutrophil counts >= 1,500/mm3 (3) Hemoglobin >= 9.0 g/dL (4) Platelets >= 75,000/mm3 (5) Total bilirubin <= 1.5 mg/dL (6) Aspartate aminotransferase <= 100 U/L (7) Alanine aminotransferase <= 100 U/L (8) Serum creatinine <= 1.5 mg/dL
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of doses of the G-CSF per the total number of completed course of the adjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactReo Hamaguchi
Nagumo Clinic Tokyo Department of Breast Surgery
Outcome results
None listed