Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04181346
• Other study ID #: IBCC 01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: November 2019
• Source: Faculdade de Medicina do ABC
• Contact: Felipe Cruz, PhD
• Phone: 5511981388214
• Email: felipemcruz[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Drug:
• Pregabalin
antipsychotic
• Placebo
Placebo

Locations

Country	Name	City	State
Brazil	IBCC Oncologia	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving complete control of nausea and vomiting		five days