Unresectable, advanced or recurrent colorectal cancer
Conditions
Interventions
arm A: Oral administration of TSUMURA Ninjin'yoeito 9.0 g/day in 2 or 3 divided doses before or between meals, from the day 1 of the first cycle to the last day of the 8th cycle in CapeOX + Bmab thera
Sponsors
Motoo Yoshiharu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who were pathologically diagnosed unresectable advanced / recurrent colorectal cancer 2. CONUT (CONtrolling NUTritional status) score between Normal and Moderate 3. Patients who do not need nutritional intervention 4. Patients who are scheduled to undergo first line chemotherapy with capecitabine, oxaliplatin (XELOX regimen) and bevacizumab 5. Patients who had not received chemotherapy or immunotherapy for unresectable advanced / recurrent colorectal cancer 6. Age >= 20 at the time of informed consent 7. Life expectancy >= 12 weeks 8. Eastern Cooperative Oncology Group Performance status of 0-2 9. Without serious damage to major organ functions (bone marrow, heart, lung, liver, kidney, etc.), and adequate function 1) Neutrophil count >= 1,500 /mm^3 2) Platelet count >= 100,000 /mm^3 3) Hemoglobin >= 9.0 g /dL 4) Total bilirubin == 30 mL/min 9) Proteinuria =< 1+ or urine protein < 1.0 g /24hours 10. Patient who are orally intake 11. Patient who are provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who receive blood transfusion, blood products or G-CSF administration within 7 days before the day 1 of the first cycle of CapeOX + Bmab therapy 2. With brain metastases or suspected brain metastases due to clinical symptoms 3. Patients who had already received oxaliplatin 4. Patients who had received radiation therapy (including local irradiation for pain control) or resection surgery within 4 weeks before the day 1 of the first cycle of CapeOX + Bmab therapy (except the case in which the first cycle of CapeOX without Bmab can be started within 4 weeks after surgery) 5. Pleural, ascitic effusions or pericardial fluid retention which needs body cavity fluid drainage 6. Other active malignancies 7. History of severe drug hypersensitivity or allergy 8. Uncontrolled hypertension 9. Thromboembolism or history of cerebrovascular disease 10. Preexisting peripheral neuropathy by diabetes mellitus, etc. 11. Uncontrolled diabetes mellitus that need insulin administration 12. Active infections (fever >= 38 degrees centigrade) 13. Diarrhea, however in cases of colostomy, diarrhea that interferes with daily life 14. Significant ECG abnormalities or heart problems which cause clinical problems 15. Severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema etc.) 16. History of Mental disorder or central nervous disorder which cause clinical problems 17. Fresh gastrointestinal bleeding 18. Pregnant, lactating or possibly pregnancy 19. Patients who are determined not applicable for the study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maintenance of nutritional status (CONUT) 2. Incidence of non-hematological adverse events >= grade 3 of CapeOX +Bmab therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Nutritional assessment 1 (Alb, T-Chol, Total lymphocyte count, CRP) 4. Nutritional assessment 2 (Body Mass Index) 5. Hematological toxicity (RBC, Hb, WBC, Neut, PLT) 6. Incidence and amount of G-CSF administration and blood transfusion 7. Quality of life assessment (EORTC QLQ-C30) 8. Maintenance rate of relative dose intensity 9. Completion rate of CapeOX+Bmab therapy 10. CEA, CA19-9 11. Progression Free Survival 12. Nerve injury marker(pNF-H) 13. Interaction between capecitabine and Ninjin'yoeito | — |
Contacts
Public ContactYoshiharu Motoo
Fukui Saiseikai Hospital
Outcome results
None listed