UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008683
Receipt number R000010210
Scientific Title Effects of ghrelin administration after gastrectomy in patients with gastric cancer: phase II study
Date of disclosure of the study information 2012/08/14
Last modified on 2012/08/14 16:12:14

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Basic information

Public title

Effects of ghrelin administration after gastrectomy in patients with gastric cancer: phase II study

Acronym

Effects of ghrelin administration after gastrectomy in patients with gastric cancer: phase II study

Scientific Title

Effects of ghrelin administration after gastrectomy in patients with gastric cancer: phase II study

Scientific Title:Acronym

Effects of ghrelin administration after gastrectomy in patients with gastric cancer: phase II study

Region

Japan


Condition

Condition

Gastric cancer patients who underwent gastrectomy

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of exogenous ghrelin administration for postoperative appetite and body weight loss in patients with gastric cancer after undergoing gastrectomy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amount of food intake,postoperative body weight(during 7-days ghrelin administration)

Key secondary outcomes

Adverse events, appetite VAS, physiolosical examination, clinical blood examination (during 7-days ghrelin administration)


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

ghrelin administration
during 10-days
twice a day
before breakfast and before dinner

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) patients with gastric cancer more than 1 year after distal or total gastrectomy
2) with curative surgical resection and without any recurrence
3) with more than 15% body weight loss compared to preoperative body weight or less than 19 of BMI
4) Age>20 and <80 years
5) oral intake possible
6) written informed consent

Key exclusion criteria

1) with severe complication or active dual malignancy
2) judged as inappropriate by physician-in-charge

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuji Takiguchi

Organization

Osaka University School of Medicine

Division name

Gastroenterological Surgery

Zip code


Address

2-2 Yamadaoka Suita City Osaka

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University School of Medicine

Division name

Gastroenterological Surgery

Zip code


Address

2-2 Yamadaoka Suita City Osaka

TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka University School of Medicine Gastroenterological Surgery

Institute

Department

Personal name



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



Other administrative information

Date of disclosure of the study information

2012 Year 08 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially 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 08 Month 02 Day

Date of IRB


Anticipated trial start date

2009 Year 02 Month 07 Day

Last follow-up date

2012 Year 09 Month 26 Day

Date of closure to data entry

2012 Year 09 Month 26 Day

Date trial data considered complete

2012 Year 09 Month 26 Day

Date analysis concluded

2012 Year 09 Month 26 Day


Other

Other related information



Management information

Registered date

2012 Year 08 Month 14 Day

Last modified on

2012 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010210


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name