Gastric cancer or esophageal cancer
Conditions
Interventions
Anamorelin group
Two 50 mg anamorelin tablets orally once daily on an empty stomach for 12 weeks starting the day after randomization. To avoid the effects of food, the drug should be taken on an empt
Sponsors
Doki Yuichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 years or older at the time of informed consent. (2) Patients who have undergone radical surgery for gastric cancer or esophageal cancer. For gastric cancer, those who have undergone proximal gastrectomy or total gastrectomy. For esophageal cancer, those who have undergone subtotal esophagectomy and reconstruction with the gastric tube. (3) Patients who have been informed about their cancer and have provided written consent to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Patients who have undergone open chest/abdominal surgery (2) Patients who cannot resume oral intake by the 14th day after surgery (3) Patients with other malignancies (excluding carcinoma in situ) (4) Patients with diabetes mellitus under treatment and poor glycemic control. (5) Patients with a history of hypersensitivity to any of the ingredients of this product. (6) Patients with congestive heart failure. (7) Patients with myocardial infarction or angina pectoris (8) Patients with severe conduction defects (e.g., complete atrioventricular block). (9) Patients receiving the following medications: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir containing products, cobicistat containing products. (10) Patients with moderate or severe hepatic impairment (Child-Pugh class B and C). (11) Patients in other interventional studies (except those that the principal investigator determines will not affect the evaluation of this study) (12) Pregnant or lactating women who are unable to discontinue breastfeeding and who are unable to use contraception during the study period. (13) Others deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in lean body mass at postoperative three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in lean body mass 2) Oral caloric intake (during postoperative hospitalization) 3) Body weight 4) Fat weight 5) Skeletal muscle cross-sectional area 6) Fat cross-sectional area 7) Appetite, QOL 8) Blood growth hormone level 9) Grip strength, knee extension strength 10) Dysfunction after upper gastrointestinal surgery 11) Blood test: lymphocyte count, serum albumin, rapid turn-over protein, total protein, total cholesterol, triglycerides, CRP 12) Adverse events | — |
Contacts
Public ContactKotaro Yamashita
The University of Osaka Hospital
Outcome results
None listed