Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

ABC Foundation (FUABC)

Status and phase: Unknown; Phase 2

Conditions: Nausea

Treatments: Drug: Placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT04181346

IBCC 01

Details and patient eligibility

About

phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)

Full 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

Pregabalin

Experimental group

Description:

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

Treatment:

Drug: Pregabalin

Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo