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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008056
Receipt No. R000009490
Scientific Title Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment.
Date of disclosure of the study information 2012/05/30
Last modified on 2012/05/30

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Basic information
Public title Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment.
Acronym Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment.
Scientific Title Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment.
Scientific Title:Acronym Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment.
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is performed to examine the effect of early nutritional intervention with an elemental diet on the inhibition of body weight loss observed during the early postoperative period in patients who had undergone curative resection for gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Rate of body weight loss from before surgery to 6-8 weeks after surgery
Key secondary outcomes Compliance with ELENTAL nutritional indices during the study period (serum albumin, serum total protein, serum total cholesterol and peripheral blood lymphocyte count), and the frequencies and grades of adverse events

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 not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ELENTAL group: After surgery, oral administration of ELENTAL at 300 kcal/day is started when porridge or regular diet becomes ingestible, and continues for 6 to 8 weeks while the patient remains hospitalized (three times daily, between meals).
Interventions/Control_2 Control group:Only eat regular diet, not administration of ELENTAL
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients satisfying all of the following criteria and not falling under any of the exclusion criteria described below were eligible for the study. The "Japanese Classification of Gastric Carcinoma (The 14th Edition)" is utilized for this study.
ases 20
1) years of age or older
2)Cases histologically diagnosed as gastric cancer
3)Cases with clinical stage I, II or III, judged as curative resection (R0) at the end of surgery
4)Cases with a performance status (ECOG) of 0 to 2
5)Cases without prior history of chemotherapy and radiotherapy, including therapies for other cancers
6)Cases judged as suitable for satisfactory oral intake of an elemental diet
7)Cases providing written consent for receiving this diet therapy
8)Cases without any postoperative complication that may potentially interfere with the conduct of this study
Key exclusion criteria Cases meeting any of the following criteria are not included in this study.
1)Cases with synchronous or metachronous double cancers/multiple cancers
However, the following cases were eligible for the study.
- Cases with synchronous or metachronous double cancers of cervical carcinoma in situ or focal cancer in colonic adenoma
- Cases with synchronous multiple cancers in which the stage of the primary lesion is not affected by coexisting lesions
- Cases with metachronous multiple cancer (prior history of gastric cancer) with prior lesions satisfying the conditions according to "Guidelines of Japanese gastric cancer treatment (October 2010, The 3rd Edition), and endoscopic mucosal resection was performed
2)Case contraindicated for ELENTAL&reg;
3)Cases with active infections
4)Cases with uncontrolled hypertension
5)Cases with uncontrolled diabetes
6)Cases with clinically problematic cardiac disease
7)Cases with severe pulmonary disease (including interstitial pneumonia, lung fibrosis and severe pulmonary emphysema)
8)Cases with prior history of clinically problematic mental disorder or central nervous system disorder
9)Cases who are pregnant or lactating, or have childbearing potential (intention)
10)Cases participating in other clinical studies with overlapping endpoints
11)Cases judged as being unsuitable for this study by the principal investigator
Target sample size 108

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Imamura
Organization Sakai City Hospital
Division name Surgery
Zip code
Address 1-1-1, Minamiyasui-cho, Sakai
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Sakai City Hospital
Division name Surgery
Zip code
Address 1-1-1, Minamiyasui-cho, Sakai
TEL
Homepage URL
Email

Sponsor
Institute KSES
Institute
Department

Funding Source
Organization KSES
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

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 30 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 Open public recruiting
Date of protocol fixation
2011 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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
2012 Year 05 Month 30 Day
Last modified on
2012 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009490

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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