malignant tumor(only solid tumor)
Conditions
Interventions
The group(OLZ group) which received olanzapine from day1 to day4 in addition to granisetron and dexamethasone.
The group(APR group) which received aprepitant from day1 to day3 in addition to granisetr
Sponsors
Department of Surgery, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients 18 years of age or older with malignant disease who had not received previous chemotherapy 2)Patients who were scheduled to receive highly emetogenic chemotherapy 3)ECOG performance status of 0, 1, or 2. 4) a serum creatinine level of 2.0 mg per deciliter or less, an AST or ALT level that was no more than 3 times the upper limit of the normal range, and an absolute neutrophil count of at least 1500 per cubic millimeter
Exclusion criteria
Exclusion criteria: 1) nausea or vomiting in the 24 hours before enrollment 2) past history of severe cognitive compromise and central nervous system disease 3) treatment with another antipsychotic agent within 30 days before enrollment 4) concurrent abdominal radiotherapy with chemotherapy 5) chronic alcoholism 6) cardiac arrhythmia and uncontrolled congestive heart failure within the previous 6 months 7) a patient with a bowel obstruction 8) a patient with pregnancy or a patient at risk of becoming pregnant 9) a patient with contraindications to aprepitant, olanzapine, granisetron and dexamethasone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall complete response (no emetic episodes and no use of rescue medication) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| acute complete response rate(CR), delayed CR, vomiting rate, nausea rate, safety, adverse event and quality of life | — |
Countries
Japan
Contacts
Public ContactTetsu Hayashida
Keio University School of Medicine Department of Surgery
Outcome results
None listed