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

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 - Efficacy of AHCC in Female Breast Cancer Patients undergoing Adjuvant chemotherapy: Randomized, Double-blind, Placebo controlled, Phase-II Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015455

Enrollment

Registered

2014-10-20

Start date

2014-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients receiving adjuvant chemotherapy for breast cancer

Interventions

AHCC (1.0g) is orally administered after each meal from day 1 of Taxan therapy for 12 weeks Placebo (1.0g) is orally administered after each meal from day 1 of Taxan therapy for 12 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Able to give written informed consent 2. Female above age 20 and below 65 3. Histologically confirmed diagnosis of breast cancer 4. Received or receiving anthracycline based treatment(AC, EC or 5FU, FEC) and Scheduled to receive any taxane based chemotherapy for 12 weeks 5. EGOC performance status 0 or 1 6. Adequate organ and marrow function measured within 14 days of enrollment; WBC>=3,000 /mm3 Hemoglobin>=10 g/dL ALP=<805 U/L Gamma-GTP=<80 U/L TG=<300mg/dL Neutrophil>=1,500/ mm3 Thrombocyte>=75000/mm3 Total bilirubin=<2.25mg/dL AST=<90 U/L ALT=<69 U/L Serum creatinine=<1.185 mg/dL

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactKeisuke Ariyoshi

NPO JORTC JORTC Data Center

keisuke.ariyoshi@jortc.jp03-5604-9850

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026