Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

Phase 2

• Conditions: Nausea
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT04181346
• Lead Sponsor: Faculdade de Medicina do ABC

Brief 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)

Detailed Description

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 Timeline

• Study Start: 2019-09-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-27
• Last Update Submitted: 2019-11-27
• Study First Posted: 2019-11-29
• Last Update Posted: 2019-11-29
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, twice a day, from the night before chemotherapy to day 5
Pregabalin	Pregabalin	Pregabalin 75mg, twice a day, from the night before chemotherapy to day 5

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving complete control of nausea and vomiting	five days

Trial Locations

Locations (1)

IBCC Oncologia; 🇧🇷 São Paulo, SP, Brazil