UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized placebo controlled Phase III trial to evaluate the reduction effects of functional foods (AHCC) on the adverse effects of digestive tract cancer chemotherapies and the investigation of the measurement method of cacogeusia
Title of the study (Brief title)	Phase III study of functional foods (AHCC) for reduction of adverse effects of digestive tract cancer chemotherapies.
Region	Japan

Condition
Condition	digestive tract cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparing investigation of the ameliorating effecs of functional foods (AHCC) on the adverse effects and cacogeusia caused by digestive tract cancer chemotherapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Evaluation for adverse effects and taste disturbance of chemotherapy
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	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Functional food (AHCC): fixed dose
Interventions/Control_2	Non of Functional food (AHCC)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Digestive tract cancer patients treated with various chemotherapies 2)Aged 20 to 80 years old 3)Patients with no AHCC use history until start of this trial 4)Sufficient oral intake 5)Adequate organ functions 6)ECOG PS of 0 or 1 7)Written informed consent
Key exclusion criteria	1) Continuous use of other functional foods 2) Serious complicating disorders (hepatic cirrhosis, insulin administration-diabetes, cardiac disease, interstitial lung disease, kidney disease, DIC, anemia) 3) Immunodeficiency, immunedepression 4) Pregnant or nursing women 5) Past medical history of drug allergies 6) Active infectious disease 7) Past medical history of alcoholic intoxications and mental disorders 8) Inappropriate for this study judged by the attending physician 9) Under 20 years old and the adults with no capacity of judgment
Target sample size	240

Research contact person
Name of lead principal investigator	Hiroaki Yanagimoto
Organization	Kansai Medical University
Division name	Surgery Division
Address	2-5-1,Shinmachi,Hirakata,Osaka 573-1191, Japan
TEL	072-804-0101
Email	yanagimh@hirakata.kmu.ac.jp

Public contact
Name of contact person	Satoshi Hirooka
Organization	Kansai Medical University
Division name	Surgery Division
Address	2-5-1,Shinmachi,Hirakata,Osaka 573-1191, Japan
TEL	072-804-0101
Homepage URL
Email	tomot1226@yahoo.co.jp

Sponsor
Institute	Kansai Medical University
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	2017 Year 03 Month 08 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2014 Year 04 Month 27 Day
Anticipated trial start date	2014 Year 10 Month 31 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	2017 Year 03 Month 08 Day
Last modified on	2017 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030398