UMIN-CTR Clinical Trial

Basic information
Public title	Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers
Acronym	Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers
Scientific Title	Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers
Scientific Title:Acronym	Impact of enteral nutrition during chemotherapy on chemotherapy-related toxicity and response in patients with advanced esophageal cancers
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	frequency of chemotherapy-related adverse effects
Key secondary outcomes	immune function nutrition status

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2	Total parenteral nutrition support is administerd for patients who underoing the same chemotherapy during chemotherapy, in place of enteral nutrition support.
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	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
Key exclusion criteria	Patients who have: -narrowing of esophago-intestinal lumen -Serious milk allergy -Serious abnormality in liver and renal
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuichiro Doki
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
Zip code
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	+81-6-6879-3251
Email

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Miyata
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
Zip code
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	+81-6-6879-3251
Homepage URL
Email

Sponsor
Institute	Graduate School of Medicine, Osaka University, Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
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Tel
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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	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）

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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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	Completed
Date of protocol fixation	2007 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date	2007 Year 10 Month 01 Day
Last follow-up date
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Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 10 Month 31 Day
Last modified on	2013 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005364

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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