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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004483
Receipt No. 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

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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
Last 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
1st 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
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 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
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 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
Date of closure to data entry
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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