Colorectal cancer
Conditions
Interventions
One pack (Cystine 700 mg/day and Theanine 280 mg/day) to be taken after breakfast, daily oral administration
One pack (placebo) to be taken after breakfast, daily oral administration
Sponsors
Non-Profit Organization JORTC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age: 20-80 years 3. Histologically confirmed colorectal cancer 4. Capecitabine therapy will be taken after resection of colorectal cancer 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 6. Vital organ functions (listed below) are preserved within 14 days prior to registration 1) WBC >= 3000/mm3 2) Platlet >= 75000/mm3 3) Hemoglobin >= 9.0 g/dL 4) Total bilirubin <= 2.0 mg/dL 5) AST <= 100 U/L 6) ALT <= 100 U/L 7) Serum creatinine <= 1.5 mg/dL
Exclusion criteria
Exclusion criteria: 1. Past history of chemotherapy 2. Past history of radiotherapy 3. Administration of amino acid supplement (including protein supplement) 4. Prior administration of Cystine and Theanine 5. Administration of supplements derived from herbs (St. John's wort, etc.), not including multivitamins 6. Pregnant or lactating patient 7. Immunodeficiency 8. Phenylketonuria 9. Registered in other clinical trials 10. Cognitive disorder (dementia, deliria, and decreased level of consciousness, etc.) 11. Psychiatric/neurological disorder 12. Aphasia, aphonia, and dysarthria 13. Oral intake difficulty 14. Malabsorption syndrome 15. Past history of gastrectomy 16. Active gastrointestinal bleeding 17. Inappropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of Grade 1 or more diarrhea (CTCAE v4.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Score of EORTC QLQ-C30 and QLQ-CR29 2) Incidence rate of Grade 1 or more hand-foot syndrome (Classification of Blum) 3) Incidence rate of Grade 2 or more diarrhea (CTCAE v4.0) 4) Incidence rate of Grade 1 or more and Grade 2 or more adverse events (white blood cell count, neutrophill count, hemoglobin, platelet count, total bilirubin, ALP, AST, ALT, gamma-GTP, creatinine, and adverse events other than diarrhea) 5) Adherence to medication (Cystine and Theanine or placebo) 6) Completion rate of four cycles of capecitabine without interruption or reduction 7) Duration of capecitabine therapy (four cycles) 8) Total dose of capecitabine | — |
Countries
Japan
Contacts
Public ContactReo Hamaguchi
Research Hospital of the Institute of Medical Science, The University of Tokyo Department of Palliative Medicine
Outcome results
None listed