A multicenter randomized trial to evaluate the antiemetic efficacy of aprepitant for nausea and vomiting associated with chemotherapies for hematopoietic malignancies

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: 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 whole period of anti‐ neoplastic agents. Any of serotonin antagonists will be administrated for the whole period of anti‐neoplastic agents. CONDITION: Patients with hematological malignancies who are planned to receive autologous hematopoietic stem cell transplantation or chemotherapies with moderate to high risk of emesis. PRIMARY OUTCOME: The rate of patients who achieved complete response (no vomiting and no rescue use of antiemetics) within 10 days of chemotherapy. SECONDARY OUTCOME: (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). 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.
Epistemonikos ID: 17331296ccf57dc2bb2bbb03b8ee75388c9a0133
First added on: Aug 22, 2024