Anamorelin study for gastrectomized patients with unresectable advanced or recurrent gastric cancer
- Conditions
- nresectable advanced or recurrent gastric cancer and cachexiaCancer cachexia, Gastric cancer, Gastrectomy
- Registration Number
- JPRN-jRCTs051210108
- Lead Sponsor
- Doki Yuichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
(1) Recurrent gastric cancer over 3 months after gastrectomy or unrectable advanced gastric cancer
(2) Planning a new line of 1st-3rd chemotherapy or receiving 1st-3rd chemotherapy
(3) Involuntary weight loss of >=5% observed within the previous 6 months
(4) Fulfilling at least 2 items of following criteria
1. Fatigue
2. Decreased general muscle strength
3. Fulfilling at least one item of following criteria
i. CRP>0.5mg/dL
ii. Hb<12g/dL
iii. Alb<3.2g/dL
(5) Aged>=20 years at the time of informed consent
(6) Life expectancy >= 4 months from the time of informed consent
(7) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
(8) Adequate organ (Bone marrow, hepatic, renal) function
1. WBC: >=2,500/mm3, <12,000/mm3
2. Plt: >=10x104/mm3
3. Hb: >=8g/dL
4. AST (GOT): <=150U/L
5. ALT (GPT): <=180U/L
6. Cre: <=2.0mg/dL
(9) with written informed consent
(1) Previous history of administration of anamorelin
(2) Previous history of allergy for ingredients of anamorelin
(3) Previous history of congestive heart failure
(4) Myocarical infarction or cardica angina
(5) Severe dysfunction of impulse conducting system (complete AV block etc.)
(6) Taking prescription medications with: Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Telaprevir, Voriconazole, Ritonavir, Cobicistat
(7) Moderate liver dysfunction (Child-Pugh classification B or C)
(8) Inability of taking orally due to bowel abnormality (e.g., bowel obstruction)
(9) Poor control of diabetes mellitus
(10) Pregnant or possibility of pregnancy
(11) Active synchronous or metachronous malignancies (excluding carcinoma in situ)
(12) Self-contained mechanical device such as pacemaker
(13) Judged by doctors as inadequate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of lean body mass
- Secondary Outcome Measures
Name Time Method 1. Transition of lean body mass<br>2. Change in body weight<br>3. Transition of body weight<br>4. Body composition (Fat mass)<br>5. Transition of body composition (Fat mass)<br>6. Skeletal muscle index (SMI)<br>7. Transition of Cancer fatigue scale <br>8. Grip strength<br>9. Transition of grip strength <br>10. Relative Dose Intensity of chemotherapy<br>11. Change of QOL-ACD score<br>12. Transition of QOL-ACD score<br>13. Blood examinations for assessment of nutritional states <br>14. CTCAE grade of 3 items related with chemotherapy-induced adverse events: anorexia, nausea, vomiting<br>15. Chemotherapy response judged by RECIST ver1.1