FindTrial
Sign In

Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04181346
Enrollment
82
Registered
2019-11-29
Start date
2019-09-01
Completion date
2020-02-28
Last updated
2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea

Keywords

pregabalin, nausea

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.

Interventions

DRUGPregabalin

antipsychotic

DRUGPlacebo

Placebo

Sponsors

Faculdade de Medicina do ABC
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double blinding

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frame
Percentage of patients achieving complete control of nausea and vomitingfive days

Countries

Brazil

Contacts

Primary ContactFelipe Cruz, PhD
felipemcruz@yahoo.com.br5511981388214
Backup ContactJuliana Mauri, Dr
julianamauri@ibcc.org.br5511981366024

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026