Gastrointestinal cancers (gastric cancer, pancreatic cancer, colorectal cancer) with cancer cachexia
Conditions
Interventions
Ninjin'yoeito, anamorelin
Sponsors
YAMAGUCHI Toshifumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 20 years or older at the time of registration. 2. Patients histologically diagnosed with malignant tumors of the stomach, colon, or pancreas. 3. Patients diagnosed as unresectable for cure based on imaging studies. 4. Patients with fatigue of Grade 1 or higher as defined by CTCAE. 5. Patients who meet the eligibility criteria for anamorelin. 6. Patients with a Performance Status (PS) of 0-2 who are eligible for chemotherapy. 7. Patients who meet one of the following criteria at the time of registration: Patients scheduled to start new chemotherapy or to change their regimen. Patients who have been receiving treatment with the same regimen for 4 weeks or more. 8. Patients capable of taking oral medications. 9. Patients who have provided consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of hypersensitivity to anamorelin or Ninjin'yoeito. 2. Patients who have taken anamorelin or Ninjin'yoeito within four weeks prior to the registration date. 3. Patients who are expected to change their chemotherapy regimen within four weeks from the time of registration. 4. Patients with active infections. 5. Patients with congestive heart failure. 6. Patients with myocardial infarction or angina pectoris. 7. Patients with severe conduction system disorders. 8. Patients currently taking clarithromycin, itraconazole, voriconazole, ritonavir-containing formulations, cobicistat-containing formulations, or ensitrelvir fumaric acid. 9. Patients using steroids for symptom relief. However, the use of steroids for antiemetic purposes in chemotherapy or for allergy prevention is permitted. 10. Patients with collagen disease or interstitial pneumonia requiring immunosuppressants or systemic corticosteroids, or those with renal impairment with Cr equal to or greater than 1.5 mg/dL. 11. Patients with moderate or severe hepatic impairment (Child-Pugh class B or C). 12. Patients with AST greater than 100 IU/L or ALT greater than 100 IU/L. For patients with liver metastases: AST greater than 200 IU/L or ALT greater than 200 IU/L. 13. Patients with difficulty in oral intake of food due to organic gastrointestinal abnormalities such as gastrointestinal obstruction. 14. Patients who are judged by the principal investigator (or sub-investigators) to be at high risk of gastrointestinal obstruction based on imaging tests. 15. Patients with uncontrolled diabetes mellitus. 16. Patients with psychiatric disorders or symptoms that make participation in the study difficult, as judged by the investigator. 17. Patients deemed inappropriate as subjects by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Cancer Fatigue Scale (CFS) score from baseline to 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CFS: Changes in Cancer Fatigue Scale (CFS) scores from baseline to 2 weeks, 8 weeks, and 12 weeks. 2. QOL-ACD (total score): Changes in QOL-ACD total scores from baseline to 2 weeks, 4 weeks, 8 weeks, and 12 weeks. 3. Biomarkers (IL-6, TNF-alpha, IGF-1): Changes in biomarker levels (IL-6, TNF-alpha, IGF-1) from baseline to 4 weeks, 8 weeks, and 12 weeks. 4. Body weight, grip strength, body composition: Changes in body weight, grip strength, and body composition from baseline to 4 weeks, 8 weeks, and 12 weeks. 5. Nutritional indicators (PNI, GPS): Changes in nutritional indicators (Prognostic Nutritional Index [PNI], Glasgow Prognostic Score [GPS]) from baseline to 4 weeks, 8 weeks, and 12 weeks. 6. Frequency of adverse events associated with chemotherapy 7. Classification analysis based on adherence rate: Participants will be classified according to their medication adherence rates, and comparative analyses will be conducted on changes in CFS, QOL-ACD, biomarkers, body weight, grip strength, body composition, nutritional indicators, and other parameters. | — |
Contacts
Public ContactHiroki YUKAMI
Osaka Medical and Pharmaceutical University Hospital
Outcome results
None listed