colorectal cancer
Conditions
Interventions
GRA+DEX (Day1-3)+APR(Day1-3) PALO+DEX(Day1)
Sponsors
Iwate Medical University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age of 20 years or older 2) Histologically confirmed colorectal cancer 3) Chemotherapy including oxaliplatin or irinotecan is planned. 4) Chemotherapy 2 courses or more by the same regimen is expected 5) Adequate function of important organs WBC >= 3000/mm3 AST < 100 IU/L ALT < 100 IU/L Ccr >= 60.0mL/min 6) Eastern Cooperative Oncology Group performance status (PS) 0-2 7) Written informed concent
Exclusion criteria
Exclusion criteria: 1) Serious or uncontrolled complication (e.g. ileus or pulmonary fibrosis, diabetes, heart failure, myocardial infarction, angina, kidney failure, liver failure, mental disorder, cerebrovascular disease, active gastroduodenal ulcer) 2) Symptomatic or clinically suspected brain metastasis 3) Convulsive disorder needs anticonvulsants 4) Ascites fluid or pleural effusion needs paracentesis 5) Pyloristenosis or intestinal obstruction 6) Evident anticipatory nausea and vomiting 7) Hypersensitivity for components of 5-HT3 receptor antagonist, NK1 receptor antagonist, dexamethasone 8) Pregnancy, lactation or who does not wish to contraception 9) Capability or intention of cooperating 10) Undesirable for the patient to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nausea (Overall study period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Nausea (acute phase, delayed phase) Complete Response (Overall study period, acute phase, delayed phase) Complete Protection (Overall study period, acute phase, delayed phase) Total Control (Overall study period, acute phase, delayed phase) Evaluation method about nausea Safety Adverse event related to DEX | — |
Countries
Japan
Contacts
Public ContactToshimoto Kimura
Iwate Medical University, School of Medicine Department of Surgery
Outcome results
None listed