A Phase II Study to Investigate the Efficacy and Safety of Oral intake of Anamorelin in Patients After Total Gastrectomy

JRCT ID: jRCTs041230012

Registered date:20/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: After Total Gastrectomy
• Date of first enrollment: 17/08/2023
• Target sample size: 65
• Study type: Interventional
• Intervention(s): Evaluation the appetite stimulating effect of oral intake of anamorelin hydrochloride (100mg/day) for 56 days in patients who have undergone total gastrectomy

Outcome(s)

• Primary Outcome: Increased appetite after 8 weeks of oral administration of anamorelin hydrochloride

Secondary Outcome

1. Increased nutrient intake after 4 weeks and 8 weeks of oral administration of anamorelin hydrochloride
2. Weight gain after 4 weeks and 8 weeks of oral administration of anamorelin hydrochloride
3. Adverse events of oral anamorelin hydrochloride
4. Total number of days of oral administration of anamorelin hydrochloride
5. Nutritional status (physical function, nutrient intake, body composition, nutritional index (blood biochemistry test including hormones and minerals))
6.Increased appetite after 4 weeks of oral administration of anamorelin hydrochloride

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Total gastrectomy for gastric cancer has been performed for more than 1 year and no evident recurrence is observed.
2) Histologically diagnosed gastric cancer (special type is acceptable) at the time of surgery.
3) Total gastrectomy with D1+, D2, D2+ No. 10 lymph node dissection or D2+PAND, and there was no residual cancer macroscopically at the time of surgery (residual tumor at surgery was R0 or R1).
4) Any distance of esophageal involvement, with the exception of cases of right open chest with concomitant sub-total esophagectomy.
5) The surgical approach performed was one of the following.
1 Open total gastrectomy was performed regardless of the degree of preoperative
clinical staging.
2 Laparoscopic or robot-assisted total gastrectomy was performed regardless of the
degree of the preoperative clinical staging. The operator or teaching assistant for laparoscopic or robot-assisted surgery must be performed by the surgeon technically certified by the Japanese Society for Endoscopic Surgery.
6) Age at the time of informed consent is 85 years old or younger.
7) Acceptable after total remnant gastrectomy.
8) It does not matter whether preoperative chemotherapy or postoperative adjuvant chemotherapy were performed or not, but it is necessary that more than 4 weeks have passed since the end of postoperative chemotherapy at the time of registration.
9) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0 or 1.
10) It is judged that oral intake is possible and oral administration of anamorelin hydrochloride (Edolmizu Tablets) can be safely started.
11) The latest test value within 84 days before registration (same day of the week 1 week before the registration date is acceptable) meets all of the following.
1 White blood cell count>= 3,000/mm3
2 Hemoglobin>=8.0g/dL
3 Platelet count>= 100,000/mm3
4 AST<=100U/L, ALT<=100U/L
5 Total bilirubin<= 2.0mg/dL
6 Serum creatinine<= 2.0 mg/dL
12) A score of 17 or less out of 20 on the FAACT anorexia questionnaire.
13) Written consent has been obtained from the patient to participate in this study.

Exclude criteria

1) Diabetes mellitus,cardiopulmonary disease, osteoarthritis, neurological disease, etc., make safe evaluation and intervention difficult.
2) Diagnosed with myocardial infarction or unstable angina within 6 months of registration.
3) Complicated with psychosis or psychiatric symptoms, and it is judged difficult to participate in clinical trials.
4) Diagnosed with dementia.
5) Inability to digest or absorb food or oral medications (chronic nausea, vomiting, diarrhea, gastrointestinal obstruction, hypercalcemia, patients under parenteral nutrition management, gastrointestinal organics associated with radiotherapy) disability, etc.)
6) Patients receiving the following drugs and foods: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing preparations, cobicistat-containing preparations, carbamazepine, phenytoin, phenobarbital, rifabutin, rifampicin, St. John's wort, containing food, grapefruit.
7) Diagnosed with moderate or severe liver dysfunction (Child-Pugh classification B and C).
8) Meet any of the following cardiac function criteria
1 Angina pectoris or myocardial infarction within the past 3 months
2 Patients with second- or third-degree atrioventricular block
3 Sinus bradycardia with a heart rate of less than 40 beats/minute, sinoatrial block, sick
sinus syndrome, or persistent arrhythmia greater than Grade 2 (Patients with stable
chronic atrial fibrillation receiving anticoagulant therapy should allow)
4 Complete left bundle branch block, complete right bundle branch block with advanced
axial variation, severe premature ventricular contractions (multifocal, 2 or more shots, or
R on T phenomenon)
5 Patients with congestive heart failure or decreased cardiac function
9) In addition, the attending physician is judged to be inappropriate for registration in this clinical trial.
10) Has a history of hypersensitivity to ingredients of anamorelin hydrochloride (Edolmizu Tablets).

Related Information

• Primary Sponsor: Bando Etsuro