phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)
chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy. All patients will receive IV ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg, bd, on days 2 and 3. Patients will be randomly assigned to take pregabalin 75 mg or placebo, bd, from the night before chemotherapy to day 5.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
antipsychotic
Placebo
IBCC Oncologia
São Paulo, São Paulo, Brazil
RECRUITINGPercentage of patients achieving complete control of nausea and vomiting
Time frame: five days
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