This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified Hesketh classification for antiemetic therapy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
86
Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.
Gruppo Italiano Studio Linfomi
Modena, Italy
overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)
Time frame: 0-120 hours
rate of Complete Response
Time frame: within the first 24 h after chemotherapy and 24-120 h
number of emetic episodes
Time frame: within the first 24 h after chemotherapy and 24-120 h
presence of nausea graded according to Likert scale
Time frame: within the first 24 h after chemotherapy and 24-120 h
time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)
Time frame: within the first 24 h after chemotherapy and 24-120 h
patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)
Time frame: within the first 24 h after chemotherapy and 24-120 h
toxic effects of Palonosetron
Time frame: within the first 24 h after chemotherapy and 24-120 h
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