Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting
NCT ID: NCT04181346
Last Updated: 2019-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
82 participants
INTERVENTIONAL
2019-09-01
2020-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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Pregabalin
Pregabalin 75mg, twice a day, from the night before chemotherapy to day 5
Pregabalin
antipsychotic
Placebo
Placebo, twice a day, from the night before chemotherapy to day 5
Placebo
Placebo
Interventions
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Pregabalin
antipsychotic
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years or older;
* Eastern Cooperative Oncology Group \< 2
Exclusion Criteria
* 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;
18 Years
ALL
No
Sponsors
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Faculdade de Medicina do ABC
OTHER
Responsible Party
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Felipe Melo Cruz
PhD, Head of Medical Oncology Department
Locations
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IBCC Oncologia
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Felipe Cruz, PhD
Role: primary
Juliana Mauri, Dr
Role: backup
Other Identifiers
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IBCC 01
Identifier Type: -
Identifier Source: org_study_id