Pancreatic cancer Gastric cancer Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Asahikawa Medical University Department of Medicine, Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology
Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital Asahikawa City Hospital Japanese Red Cross Asahikawa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who receives Anamorelin treatment 1) aged 20 years old or above 2) diagnosed as pancreatic cancer, gastric cancer or colorectal cancer by clinical imaging or other modalities 3) histologically proven cancer patients (including class IV by cytology or group IV by histology) 4) patients with unresectable state 5) written consent obtained from the patients or their legal representative 6) cancer cachexia patients who haven't improved general condition by nutritional support 7) Patients who have been losing weight more than 5% in the last 6 months and had more than 2 following symptoms; 7-1)Fatigue or malaise 7-2)Loss of muscular strength 7-3)Having 1 or more following data; CRP over 0.5mg/dl, Hb less than 12g/dl or Alb less than 3.2g/dl 2. Patients who does not receive Anamorelin treatment 1) aged 20 years old or above 2) diagnosed as pancreatic cancer, gastric cancer or colorectal cancer by clinical imaging or other modalities 3) histologically proven cancer patients (including class IV by cytology or group IV by histology) 4) patients with unresectable state 5) written consent obtained from the patients or their legal representative
Exclusion criteria
Exclusion criteria: 1. Patients who receives Anamorelin treatment 1) under 20 years old 2) Patients with severe cardiac disease 3) Patients with severe liver disease (Child-Pugh B or C) 4) Patients with severe psychologic disease 5) Patients who is taking medications as follows; Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Telaprevir, Voriconazole, Ritonavir-containing agent or Cobicistat-containing agent 6) Unable to oral intake due to gastrointestinal occlusion or other organic gastrointestinal disorders 7) Unable to take part in this study due to other severe complication 8) Disqualified to take part in this study judged by attending/primary doctors 9) Patients with congestive heart failure, myocardial infarction, angina pectoris or severe cardiac conduction abnormalities 2. Patients who does not receive Anamorelin treatment 1) under 20 years old 2) Patients with severe cardiac disease 3) Patients with severe liver disease (Child-Pugh B or C) 4) Patients with severe psychologic disease 5) Unable to oral intake due to gastrointestinal occlusion or other organic gastrointestinal disorders 6) Unable to take part in this study due to other severe complication 7) Disqualified to take part in this study judged by attending/primary doctors When the patient is determined not to qualify taking part in this study after the registration, the patients will be excluded from the study immediately.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in QOL between non-Anamorelin usage and Anamorelin usage patients in 24 weeks (assessed by EORTC QLQ-C30) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall difference in QOL between non-Anamorelin usage and Anamorelin usage patients in 4, 12, 36 and 48 weeks (assessed by EORTC QLQ-C30) 2) Differences in QOL between non-Anamorelin usage and Anamorelin usage patients in 4, 12, 36 and 48 weeks by cancer types (assessed by EORTC QLQ-C30) 3) Progression free survival between non-Anamorelin usage and Anamorelin usage patients (analyzed by cancer types) 4) Overall survival between non-Anamorelin usage and Anamorelin usage patients (analyzed by cancer types) 5) Differences in skeletal muscle index between non-Anamorelin usage and Anamorelin usage patients in 12, 36 and 48 weeks (assessed by CT L3 level cross sectional imaging) 6) Differences in fat pad quantity between non-Anamorelin usage and Anamorelin usage patients in 12, 36 and 48 weeks (assessed by CT L3 level/umbilicus cross sectional imaging) 7) Differences in Neutrophil-to-Lymphocyte ratio, Platelet-to-Lymphocyte ratio, Prognostic Nutritional Index and modified Glasgow Prognostic Score between non-Anamorelin usage and Anamorelin usage patients in 4,8,12,24,36 and 48 weeks 8) Differences in serum Myostatin and ActivinA between non-Anamorelin usage and Anamorelin usage patients in 4,8,12,24,36 and 48 weeks 9) Differences in serum Myostatin and ActivinA between skeletal muscle index increased patients and skeletal muscle decreased patients in 12 and 24 weeks 10) Differences in skeletal muscle index between QOL increased and QOL decreased patients in 24 and 48 weeks. 11) Differences in body weight between Anamorelin usage and non-Anamorelin usage patient in 4, 8, 12, 24, 36 and 48 weeks | — |
Countries
Japan
Contacts
Public ContactHiroki Sato
Asahikawa Medical University Department of Internal Medicine, Division of Gastroenterology
Outcome results
None listed