Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

NCT04181346 | Unknown Phase 2 DMC

• 1 other identifier: IBCC 01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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)

Conditions

Nausea

Keywords

pregabalin; nausea

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving complete control of nausea and vomiting

  five days

Study Arms (2)

Pregabalin

EXPERIMENTAL

Pregabalin 75mg, twice a day, from the night before chemotherapy to day 5

Drug: Pregabalin

Placebo

EXPERIMENTAL

Placebo, twice a day, from the night before chemotherapy to day 5

Drug: Placebo

Interventions

Pregabalin DRUG

antipsychotic

Also known as: Lyrica

Pregabalin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Faculdade de Medicina do ABC: lead

Study Sites (1)

IBCC Oncologia

São Paulo, São Paulo, 03102002, Brazil

RECRUITING

MeSH Terms

Conditions

Nausea

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Felipe Cruz, PhD

CONTACT

5511981388214; felipemcruz@yahoo.com.br

Juliana Mauri, Dr

CONTACT

5511981366024; julianamauri@ibcc.org.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Head of Medical Oncology Department

Model Details: chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy will be randomized for two arms: pregabalin and placebo. All patients received 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.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 29, 2019
• Study Start: September 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)