UMIN-CTR Clinical Trial

Basic information
Official scientific title of the 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
Title of the study (Brief title)	Efficacy of AHCC in Female Breast Cancer Patients undergoing Adjuvant chemotherapy: Randomized, Double-blind, Placebo controlled, Phase-II Study
Region	Japan

Condition
Condition	Patients receiving adjuvant chemotherapy for breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of AHCC in female breast cancer patients undergoing anthracycline and taxane based adjuvant chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	AHCC (1.0g) is orally administered after each meal from day 1 of Taxan therapy for 12 weeks
Interventions/Control_2	Placebo (1.0g) is orally administered after each meal from day 1 of Taxan therapy for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key 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
Key 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
Target sample size	50

Research contact person
Name of lead principal investigator	Sho Hangai
Organization	The University of Tokyo
Division name	Dept. of Molecular Immunology, Institute of Industrial Science
Address	4-6-1, Komaba, Meguro-ku Tokyo, 153-8505 Japan
TEL	03-5452-6491
Email	hangai-tky@umin.ac.jp

Public contact
Name of contact person	Keisuke Ariyoshi
Organization	NPO JORTC
Division name	JORTC Data Center
Address	2-54-6-302, Nishinippori, Arakawa-ku, Tokyo 116-0013, JAPAN
TEL	03-5604-9850
Homepage URL
Email	keisuke.ariyoshi@jortc.jp

Sponsor
Institute	NPO Japanese Organisation for Research and Treatment of Cancer (JORTC)
Institute
Department

Funding Source
Organization	Amino Up Chemical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 14 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 17 Day
Last modified on	2017 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017961