Unique ID issued by UMIN | UMIN000004483 |
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Receipt number | R000005364 |
Scientific Title | Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers |
Date of disclosure of the study information | 2010/10/31 |
Last modified on | 2013/04/30 09:43:56 |
Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers
Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers
Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers
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 immune function
Efficacy
Exploratory
frequency of chemotherapy-related adverse effects
immune function
nutrition status
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is considered as a block.
YES
Numbered container method
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 adriamycin for advanced esophageal cancers are administered.This nutrition intervention is performed for 17 days, from 3 days before the start of chemotherapy to 7 days after the completion of chemotherapy.
Total parenteral nutrition support is administerd for patients who underoing the same chemotherapy during chemotherapy, in place of enteral nutrition support.
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
90
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
+81-6-6879-3251
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
+81-6-6879-3251
Graduate School of Medicine, Osaka University, Department of Gastroenterological Surgery
none
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)
2010 | Year | 10 | Month | 31 | Day |
Published
Completed
2007 | Year | 05 | Month | 01 | Day |
2007 | Year | 10 | Month | 01 | Day |
2010 | Year | 10 | Month | 31 | Day |
2013 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005364
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