Randomized phase II study of clinical impact of ghrelin in 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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026893

Enrollment

Registered

2017-04-30

Start date

2017-04-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer in the elderly

Interventions

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)

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Oral intake calories	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactAtsushi Gakuhara

Graduate School of Medicine, Osaka University Department of Gastroenterological Surgery

agakuhara@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026