Unique ID issued by UMIN | UMIN000011107 |
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Receipt number | R000013006 |
Scientific Title | Randomized study of clinical effect of enteral nutrition support during neoadjuvant chemotherapy on chemotherapy-related toxicity in patients with esophageal cancer |
Date of disclosure of the study information | 2013/07/03 |
Last modified on | 2015/07/16 06:53:21 |
Randomized study of clinical effect of enteral nutrition support during neoadjuvant chemotherapy on chemotherapy-related toxicity in patients with esophageal cancer
Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers
Randomized study of clinical effect of enteral nutrition support during neoadjuvant chemotherapy on chemotherapy-related toxicity in patients with esophageal cancer
Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers
Japan |
esophageal cancer
Gastrointestinal surgery |
Malignancy
NO
The aim of this study is to evaluate whether enteral nutrition during chemotherapy for advanced esophageal cancers decreases advere chemotherapy-related adverse side effect and improves nutrition status
Efficacy
Exploratory
frequency of chemotherapy-related adverse effects, especially hematotoxicity
frequency of other chemotherapy-related adverse effects
nutrition status
feasibility of agjuvant chemotherapy
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
An amount of 600ml/day of enteral nutritional supplement(Racol@ )is administerd for patients who receive chemotherapy consisting of 5-FU, cisplatin and docetaxel for advanced esophageal cancers are administered.This nutrition intervention is performed for 15 days, from 3 days before the start of chemotherapy to 7 days after the completion of chemotherapy.
An amount of 600ml/day of enteral nutritional supplement(Ensure Liquid@ )is administerd for patients who receive chemotherapy consisting of 5-FU, cisplatin and docetaxel for advanced esophageal cancers are administered.This nutrition intervention is performed for 15 days, from 3 days before the start of chemotherapy to 7 days after the completion of chemotherapy.
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients who have primary esophageal cancer which is histologically confirmed
-Performance status is 0-2
-No serious abnormality in heart, lung, bone marrow, liver, and renal functions
-obtain informed consent
Patients who have:
-narrowing of esophago-intestinal lumen
-Serious milk allergy
-Serious abnormality in liver and renal
60
1st name | |
Middle name | |
Last name | Yuichiro Doki |
Graduate School of Medicine, Osaka University
Department of Gastroenterological Surgery
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
06-6859-3251
ydoki@gesurg.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroshi Miyata |
Graduate School of Medicine, Osaka University
Department of Gastroenterological Surgery
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
06-6879-3251
kmurakami@gesurg.med.osaka-u.ac.jp
Graduate School of Medicine, Osaka University, Department of Gastroenterological Surgery
Graduate School of Medicine, Osaka University, Department of Gastroenterological Surgery
Self funding
NO
大阪大学医学部付属病院(大阪府)、大阪府立成人病センター(大阪府)、近畿大学医学部付属病院(大阪府)
2013 | Year | 07 | Month | 03 | Day |
Unpublished
Main results already published
2012 | Year | 03 | Month | 31 | Day |
2012 | Year | 07 | Month | 01 | Day |
2013 | Year | 07 | Month | 03 | Day |
2015 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013006
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