Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

Phase II Study of Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

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.

Inclusion Criteria:

• patients scheduled to receive their first cycle of moderately to highly emetogenic chemotherapy;
• 18 years or older;
• Eastern Cooperative Oncology Group < 2

Exclusion Criteria:

• Nausea or vomiting 24h before randomization
• aspartate aminotransferase / alanine aminotransferase above 3 times the upper limit
• Severe cognitive compromise;
• regular use of corticosteroids, opioid, benzodiazepines, tricyclic antidepressant, or cannabinoids within 30 days before randomization;
• brain metastasis;
• chronic alcoholism;