Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

• Status: Unknown status
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: All

Summary

phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faculdade de Medicina do ABC
• Treatments: Pregabalin

Criteria

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;