Patients with hematological malignancies who are planned to receive autologous hematopoietic stem cell transplantation or chemotherapies with moderate to high risk of emesis.
Conditions
Interventions
Aprepitant will be administrated for 5 days (125mg on the first day, 80mg for the rest of days) from the first day of chemotherapy while any of serotonin antagonists will be administrated for the whol
Sponsors
JHOCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients undergoing either of the therapies for hematological malignancies; A) Anti-neoplastic agents give for the conditioning of auto hematopoietic stem cell transplant against malignant lymphoma or multiple myeloma. B) Anti-neoplastic agents which have moderate to severe risk of emesis by NCCN antiemesis guidelines ver. 1.2011. Molecular targeted agents are excluded. 2) Patients with ECOG performance status (PS) 0-2. 3) Patients whose life expectancy is 3 months or longer . 4) Patients who are able to fill in the symptom log precisely. 5) Patients who fulfilled the conditions below on the first day of chemotherapy. a)white blood cell count >= 2000/mm3 and neutrophils >= 1000/mm3. b)AST and ALT level not exceeding 3 times the upper limit of normal (ULN). c)serum bilirubin or creatinine level not exceeding 1.5 times the ULN.
Exclusion criteria
Exclusion criteria: (1) Patients administrated antiemetic (listed table2) one or two days before the chemotherapy. (2) Patients administrated any benzodiazepines and narcotics one or two days before the chemotherapy. Exceptional use of very short acting benzodiazepine such as triazolam or midazolam is admitted once daily. The continuous use of other benzodiazepines and narcotics that had been administered 2 days before of the chemotherapy is admitted at the same dose and regimen. (3) Patients with symptomatic CNS invasion . (4) Administration of the agents listed below during the 7 days before chemotherapy: Clarithromycin, Ketoconzole, Itraconazole (5) Administration of the agents listed below during the 4 weeks before chemotherapy: barbiturate acid, rifampicin, phenytoin or carbamazepine (6) Confirmed or potential pregnancy , and wish to have a child during the study period or receiving oral contraceptives. (7) A history of allergy to serotonin antagonist or aprepitant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of patients who achieved complete response (no vomiting and no rescue use of antiemetics) within 10 days of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The rate of patients who achieved "no nausea", "no emesis", "no rescue antiemetics" and "no significant nausea" during each of early phase (from the first to the day after the last day of chemotherapy) and late phase (from 2 days after the end of chemotherapy to the end of observation). (2) Change in the index of emesis (FLIE score or VAS) before and after chemotherapy. (3)The effect of psychological scoring (STAI state anxiety) on the incidence of CINV (chemotherapy induced nausea and vomiting). | — |
Countries
Japan
Contacts
Public ContactYasuhito Nannya/Ryo Nasu
Tokyo University Hospital Department of Hematolgy & Oncology
Outcome results
None listed