RCT of Anamorelin in Postoperative Patients with Upper Gastrointestinal Cancer

JRCT ID: jRCTs051240256

Registered date:01/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer or esophageal cancer
• Date of first enrollment: 12/02/2025
• Target sample size: 160
• Study type: Interventional

Intervention(s)

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 empty stomach (upon awakening) and no food should be consumed for at least 1 hour after taking the drug.

Non-Treatment Group
Anamorelin will not be administered.

Outcome(s)

• Primary Outcome: Rate of change in lean body mass at postoperative three months.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

(1) Patients who have undergone open chest/abdominal surgery
(2) Patients who cannot resume oral intake by the 10th 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
(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.

Related Information

• Primary Sponsor: Doki Yuichiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development