UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012597
Receipt number R000014732
Scientific Title The effect of preoperative oral nutritional supplement (ONS) on the prognostic nutritional Index (PNI) in patients undergoing gastrectomy for gastric cancer
Date of disclosure of the study information 2013/12/17
Last modified on 2013/12/16 18:14:08

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Basic information

Public title

The effect of preoperative oral nutritional supplement (ONS) on the prognostic nutritional Index (PNI) in patients undergoing gastrectomy for gastric cancer

Acronym

The effect of preoperative ONS on the PNI in patients undergoing gastrectomy for gastric cancer

Scientific Title

The effect of preoperative oral nutritional supplement (ONS) on the prognostic nutritional Index (PNI) in patients undergoing gastrectomy for gastric cancer

Scientific Title:Acronym

The effect of preoperative ONS on the PNI in patients undergoing gastrectomy for 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 the influence of the preoperative nutritional intervention with enteral nutrients on the PNI in patients undergoing gastrectomy for gastric cancer with the PNI of <48.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Change of the PNI

Key secondary outcomes

(1) Nutritional status
(2) Body weight and body mass index
(3) Performance status
(4) Adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

In addition to a meal, an enteral nutrient (Racol&#174;NF) is administered 3 times per day (600 kcal / day) for 20 days or longer before the operation.

Interventions/Control_2


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) Histologically confirmed gastric cancer
(2) No prior chemotherapy
(3) An age of 20 - 80
(4) A PNI of <48
(5) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
(6) Sufficient function of the liver, kidney and bone marrow
(7) Sufficient oral intake
(8) Written informed consent

Key exclusion criteria

(1) Preoperative chemotherapy or chemoradiotherapy
(2) Severe bowel obstruction
(3) Short-bowel syndrome
(4) Severe liver or renal dysfunction
(5) Uncontrolled diabetes mellitus
(6) Congenital amino acid abnormalities
(7) Milk protein allergy or soy protein allergy
(8) Electrolyte abnormalities
(9) Pregnancy or insufficient contraception
(10) Severe mental disease

Target sample size

61


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoyoshi Takayama, MD

Organization

Nara Medical University

Division name

Department of Surgery

Zip code


Address

840 Shijo-Cho, Kashihara, 634-8522, Japan

TEL

0744-29-8863

Email

t-taka@naramed-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyoshi Takayama, MD

Organization

Nara Medical University

Division name

Department of Surgery

Zip code


Address

840 Shijo-Cho, Kashihara, 634-8522, Japan

TEL

0744-29-8863

Homepage URL


Email

t-taka@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Nara Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


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

奈良県立医科大学附属病院


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 17 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

Enrolling by invitation

Date of protocol fixation

2013 Year 07 Month 24 Day

Date of IRB


Anticipated trial start date

2013 Year 08 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

2013 Year 12 Month 16 Day

Last modified on

2013 Year 12 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014732


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name