UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026461
Receipt No. R000030398
Scientific Title 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
Date of disclosure of the study information 2017/03/08
Last modified on 2017/03/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym Phase III study of functional foods (AHCC) for reduction of adverse effects of digestive tract cancer chemotherapies.
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroaki Yanagimoto
Organization Kansai Medical University
Division name Surgery Division
Zip code
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
1st name
Middle name
Last name Satoshi Hirooka
Organization Kansai Medical University
Division name Surgery Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2014 Year 04 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.