Unique ID issued by UMIN | UMIN000026893 |
---|---|
Receipt number | R000030193 |
Scientific Title | Randomized phase II study of clinical impact of ghrelin in elderly patients with gastric cancer in early postoperative period. |
Date of disclosure of the study information | 2017/04/30 |
Last modified on | 2019/01/15 12:53:41 |
Randomized phase II study of clinical impact of ghrelin in elderly patients with gastric cancer in early postoperative period.
Clinical trial of ghrelin for elderly patients with gastric cancer in early postoperative period.
Randomized phase II study of clinical impact of ghrelin in elderly patients with gastric cancer in early postoperative period.
Clinical trial of ghrelin for elderly patients with gastric cancer in early postoperative period.
Japan |
gastric cancer in the elderly
Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of ghrelin administration for elderly patients with gastric cancer after gastrectomy in early postoperative period.
Safety,Efficacy
Exploratory
Phase II
Oral intake calories
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
Interventional
Parallel
Randomized
Cluster
Single blind -participants are blinded
Placebo
2
Treatment
Medicine |
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
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
75 | years-old | <= |
Not applicable |
Male and Female
(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
(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.
20
1st name | |
Middle name | |
Last name | Yuichiro Doki |
Graduate School of Medicine, Osaka University
Department of Gastroenterological Surgery
2-2, E2, Yamadaoka, Suita, Osaka
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Atsushi Gakuhara |
Graduate School of Medicine, Osaka University
Department of Gastroenterological Surgery
2-2, E2, Yamadaoka, Suita City, Osaka
06-6879-3251
agakuhara@gesurg.med.osaka-u.ac.jp
Department of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University
none
Self funding
NO
2017 | Year | 04 | Month | 30 | Day |
Unpublished
Terminated
2017 | Year | 02 | Month | 09 | Day |
2017 | Year | 04 | Month | 30 | Day |
2017 | Year | 04 | Month | 07 | Day |
2019 | Year | 01 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030193
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |