UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008056
Receipt number 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 12:55:58

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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 or person

Institute

KSES

Institute

Department

Personal name



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

Value
https://center6.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