UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study of clinical impact of ghrelin in elderly patients with gastric cancer in early postoperative period.
Title of the study (Brief title)	Clinical trial of ghrelin for elderly patients with gastric cancer in early postoperative period.
Region	Japan

Condition
Condition	gastric cancer in the elderly
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of ghrelin administration for elderly patients with gastric cancer after gastrectomy in early postoperative period.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Oral intake calories
Key secondary outcomes	1)Appetite (VAS) 2)Body weight loss rate 3)Body composition 4)Postoperative complications rate 5)Postoperative hospitalization 6)QOL 7)Hormone measurement 8)Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In ghrelin group (n=10), patients with gastric cancer are recieved intravenous synthetic human ghrelin (0.25 micro g/kg/min) administration for 5 days from operative day (immediately after operation) and then synthetic human ghrelin (3 micro g/kg) administration for intravenously repeated bid for 5 days
Interventions/Control_2	In placebo group (n=10), patients with gastric cancer are recieved intravenous synthetic human ghrelin (0.25 micro g/kg/min) administration for 5 days from operative day (immediately after operation) and then synthetic human ghrelin (3 micro g/kg) administration for intravenously repeated bid for 5 days
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Histologically proven gastric carcinoma (2)Distal gastrectomy or total gastrectomy (3)R0 resection or R1 resection solely by CY1 can be obtained (4)Clinical H0, P0, M0 (5) Aged more than 75 years old (only distal gastrectomy, more than 80 years old) (6) Eastern Cooperative Oncology Group (ECOG) PS of 0-2 (7) No obvious organ failures and satisfy the following laboratory data within 28 days before registration: WBC >=3,000/mm3 WBC<12,000/mm3 Platelet >= 100,000/mm3 Hb >= 8.0 g/dL AST <= local reference range 2 ALT <= local reference range 2 T.Bil <= 2.0 mg/dL Creatinin <= 1.5 mg/dL (8)Provided written informed consent
Key exclusion criteria	(1)Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ (2) Patients combined resection of other organs except for gallbradder and spleen. (3) Severe respiratory disease. (4)History of myocardial infarction or unstable angina pectoris within six months. (5) Liver cirrhosis or active hepatitis. (6) Chronic renal failure with hemodialysis. (7) Uncontrolled diabetes mellitus (HbA1c 9.0 or more). (8) Other unfeasible factors to perform study safely approved by attending surgeon.
Target sample size	20

Research contact person
Name of lead principal investigator	Yuichiro Doki
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
Address	2-2, E2, Yamadaoka, Suita, Osaka
TEL	06-6879-3251
Email	ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Atsushi Gakuhara
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
Address	2-2, E2, Yamadaoka, Suita City, Osaka
TEL	06-6879-3251
Homepage URL
Email	agakuhara@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University
Institute
Department

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)

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	2017 Year 04 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 02 Month 09 Day
Anticipated trial start date	2017 Year 04 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 07 Day
Last modified on	2019 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030193