Hematological malignancies
Conditions
Interventions
Sponsors
Kyoto University Hospital,Department of Hematology and Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Received the chemotherapy for blood tumor 2. able to record the onset of vomiting and nausea in a symptom diary 3. patients who induced nausea and vomiting and anorexia and rescue therapy in the first chemotherapy. 4. Performance Status(PS) of 0-2 5. estimated life expectancy of at least 3 months 6. aspartate aminotransferase (AST) (glutamic oxaloacetic transaminase (GOT)) and alanine aminotransferase(ALT) (glutamic pyruvic transaminase (GPT))<2.5 x upper limit of the normal range at the facility 7. total bilirubin <1.5 x upper limit of the normal range at the facility 8. creatinine <1.5 x upper limit of the normal range at the facility
Exclusion criteria
Exclusion criteria: 1. chemotherapy within 6 days before study day 1 or between days 1 to 6. 2. Antiemetic therapy prior to 48 hr of chemotherapy. 3. Corticosteroids therapy within 72 hr before study day 1 or duration of study 4. Radiation therapy to the abdomen or pelvis within 6 days before study day 1 or duration of study 5. known central nervous system malignancy 6. following drug therapy within 6 days before study day 1 - clarithromycin, ketoconazole, itraconazole - 7. following drug therapy within 4 weeks before study day 1 - barbiturate, rifampicin, phenytoin, carbamazepine - 8. pregnant, nursing or possibly pregnant women 9. Patients judged inappropriate for this study by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of the incidence of nausea and vomiting | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with Complete Response (no emesis and no rescue therapy) in the overall phase (0-120 hour after administration of antitumor agent). The proportion of patients with Complete Response ( no emesis and no rescue therapy ) in Day 1 or Day 2 - Day 5. | — |
Countries
Japan
Contacts
Public ContactTadakazu Kondo
Kyoto University Hospital Department of Hematology and Oncology
Outcome results
None listed