UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026461
Receipt number 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 15:16:01

* 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 or person

Institute

Kansai Medical University

Institute

Department

Personal name



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

Value
https://center6.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