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Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

Primary Purpose

Nausea

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Pregabalin

Placebo

About this trial

This is an interventional treatment trial for Nausea focused on measuring pregabalin, nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

IBCC OncologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Pregabalin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of patients achieving complete control of nausea and vomiting

Secondary Outcome Measures

Full Information

NCT ID

NCT04181346

First Posted

November 22, 2019

Last Updated

November 27, 2019

Sponsor

Faculdade de Medicina do ABC

1. Study Identification

Unique Protocol Identification Number

NCT04181346

Brief Title

Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

February 28, 2020 (Anticipated)

Study Completion Date

February 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Faculdade de Medicina do ABC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea

Keywords

pregabalin, nausea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigator

Masking Description

double blinding

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pregabalin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

antipsychotic

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Percentage of patients achieving complete control of nausea and vomiting

Time Frame

five days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Felipe Cruz, PhD

Phone

5511981388214

felipemcruz@yahoo.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Juliana Mauri, Dr

Phone

5511981366024

julianamauri@ibcc.org.br

Facility Information:

Facility Name

IBCC Oncologia

City

São Paulo

State/Province

ZIP/Postal Code

03102002

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Felipe Cruz, PhD

Phone

5511981388214

felipemcruz@yahoo.com.br

First Name & Middle Initial & Last Name & Degree

Juliana Mauri, Dr

Phone

5511981388214

julianamauri@ibcc.org.br

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

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