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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006499
Receipt No. R000007710
Scientific Title The study of the safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer.
Date of disclosure of the study information 2011/10/20
Last modified on 2015/05/01

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Basic information
Public title The study of the safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer.
Acronym Safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer.
Scientific Title The study of the safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer.
Scientific Title:Acronym Safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer.
Region
Japan

Condition
Condition Gastric 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 nutritional therapy by elemental diet could increase the rate of initiating adjuvant chemotherapy and improve nutritional status in patients with gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The rate of initiating adjuvant chemotherapy within 6 weeks after surgery.
Key secondary outcomes 1)total rate of initiating adjuvant chemotherapy after surgery
2)incidence of diarrhea
3)nutritional status
4)safety and tolerability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients assigned to trial group take elemental diet (ELENTAL) at least more than one pack a day from the 3rd post-operative day for 6 weeks.
All the patients including trial group take conventional post-operative meals from the 3rd post-operative day.
Interventions/Control_2 All the patients including trial group take conventional post-operative meals from the 3rd post-operative day.
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 1)age. 20<= and 80>=
2)planned to receive adjuvant chemotherapy by TS-1 within 6 weeks after surgery.
3)patients with fully understood the study procedures given informed consent after a sufficient explanation.
Key exclusion criteria 1)patient under some organ failure
2)with other severe diseases
3)patient relevant to contraindication to all use drugs
4)considered inadequate for inclusion in this trial by the physician
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akinori Takagane
Organization Hakodate Goryoukaku Hospital
Division name Department of Surgery
Zip code
Address 38-3,Goryoukaku-chou,Hakodate,Hokkaido
TEL 0138-51-2295
Email takagane@gobyou.com

Public contact
Name of contact person
1st name
Middle name
Last name Akinori Takagane
Organization Hakodate Goryoukaku Hospital
Division name Department of Surgery
Zip code
Address 38-3,Goryoukaku-chou,Hakodate,Hokkaido
TEL 0138-51-2295
Homepage URL
Email takagane@gobyou.com

Sponsor
Institute Hakodate Goryoukaku Hospital
Department of Surgery
Institute
Department

Funding Source
Organization Ajinomoto Pharmaceuticals Co.,Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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 函館五稜郭病院(北海道)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2011 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2014 Year 07 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 10 Day
Date trial data considered complete
2015 Year 03 Month 22 Day
Date analysis concluded
2015 Year 04 Month 06 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 07 Day
Last modified on
2015 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007710

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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