Placebo-controlled,double-blind,randomized study of comparing NK1 receptor antagonist/ palonosetoron/ dexamethasone on day 1+-dexamethasone on day2/3 in high emetogenic chemotherapy
- Conditions
- Malignancy
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 400
Not provided
(1) Hematopoietic malignancy (2) Known brain metastasis (3) Patients who cannot use cortico steroid (4) Patients taking systemic corticosteroid (topical and inhaled steroid are allowed). (5) Patients with a history of administration of highly emetogenic chemotherapy (6) Patients scheduled to receive moderately to highly emetogenic chemotherapy six days before and six after the day of highly emetogenic agent administration. (Minimally to low emetogenic agents are allowed). (7) Patients with history of or scheduled to receive radiation therapy to abdomen (below diagphram) or to pelvis from six days before chemotherapy to six days after chemotherapy. (8) Patient taking antiemetics other than study drug. (9) Patients who had a hypersensitivity reaction to NK1 receptor antagonist or palonosetoron or dexamethasone (10) Patients who are intolerant to chemotherapy (11) Pregnant, breastfeeding or expecting woman (12) Patients with uncontrolled diabetes (13) HBs are positive (14) Patients with active infection (15) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with complete response (no vomiting and no rescue medication use) during the 120 hours observation period after the infusion of chemotherapy.
- Secondary Outcome Measures
Name Time Method (1)Complete response rate during acute phase (0-24hr) and delayed phase (24-120hr). (2)Severity of nausea on/using Likert scale from day1 to 5 study period. (3)Adverse events related to steroid administrarion. (4)Quality of life score using EORCT QLQ-C30 on the day before chemotherapy administration and overall five days study period. (5)Adverse events defined as grade3 or higher/more on CTCAE ver 4.0