Unique ID issued by UMIN | UMIN000026461 |
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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 |
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
Phase III study of functional foods (AHCC) for reduction of adverse effects of digestive tract cancer chemotherapies.
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
Phase III study of functional foods (AHCC) for reduction of adverse effects of digestive tract cancer chemotherapies.
Japan |
digestive tract cancer
Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Hepato-biliary-pancreatic surgery |
Malignancy
NO
Comparing investigation of the ameliorating effecs of functional foods (AHCC) on the adverse effects and cacogeusia caused by digestive tract cancer chemotherapy
Efficacy
Confirmatory
Pragmatic
Phase III
Evaluation for adverse effects and taste disturbance of chemotherapy
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is considered as a block.
NO
Central registration
2
Treatment
Food |
Functional food (AHCC): fixed dose
Non of Functional food (AHCC)
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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
240
1st name | |
Middle name | |
Last name | Hiroaki Yanagimoto |
Kansai Medical University
Surgery Division
2-5-1,Shinmachi,Hirakata,Osaka 573-1191, Japan
072-804-0101
yanagimh@hirakata.kmu.ac.jp
1st name | |
Middle name | |
Last name | Satoshi Hirooka |
Kansai Medical University
Surgery Division
2-5-1,Shinmachi,Hirakata,Osaka 573-1191, Japan
072-804-0101
tomot1226@yahoo.co.jp
Kansai Medical University
Amino Up Chemical Co., Ltd.
Profit organization
NO
2017 | Year | 03 | Month | 08 | Day |
Unpublished
2014 | Year | 04 | Month | 27 | Day |
2014 | Year | 10 | Month | 31 | Day |
2017 | Year | 03 | Month | 08 | Day |
2017 | Year | 03 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030398
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