NYX study

JRCT ID: jRCTs041190071

Registered date:02/10/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Unresectable, advanced or recurrent colorectal cancer
• Date of first enrollment: 14/03/2020
• Target sample size: 150
• Study type: Interventional

Intervention(s)

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 therapy.
arm B: Non-treatment of TSUMURA Ninjin'yoeito.

Outcome(s)

Primary Outcome

1. Maintenance of nutritional status (CONUT)
2. Incidence of non-hematological adverse events >= grade 3 of CapeOX +Bmab therapy

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 =< 2.5 x Upper Limit of each medical institution
5) Aspartate aminotransferase and alanine aminotransferase =< 5.0 x Upper Limit of each medical institution
6) Alkaline Phosphatase =< 4.0 x Upper Limit of each medical institution
7) Serum creatinine =< 1.5 x Upper Limit of each medical institution
8) eGFR (estimated glomerular filtration rate) >= 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

Exclude 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

Related Information

• Primary Sponsor: Motoo Yoshiharu
• Source(s) of Monetary Support: TSUMURA and Co.