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Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

Primary Purpose

Vomiting, Cisplatin Adverse Reaction

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
Gabapentin
Sponsored by
Faculdade de Medicina do ABC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vomiting focused on measuring Vomiting, Antiemetics, Dexamethasone, Cisplatin, Antineoplastic combined chemotherapy protocols

Eligibility Criteria

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

Inclusion Criteria:

  • First course of chemotherapy ( cisplatin or doxorubicin at a dose of at least 50mg per square meter)
  • Written informed consent must be obtained before initiating the protocol procedures

Exclusion Criteria:

  • ECOG 3
  • Nausea and vomiting within the past 1 day
  • Gastrointestinal obstruction
  • Concurrent use of opioid
  • Patients with brain metastases
  • History of allergic or other adverse reaction to gabapentin

Sites / Locations

  • Faculdade de Medicina do ABC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Gabapentin

Arm Description

Placebo: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily

Gabapentin 300mg: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily

Outcomes

Primary Outcome Measures

Number of Patients With Complete Response During Chemotherapy Course 1
The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)
Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1
Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy

Secondary Outcome Measures

Full Information

First Posted
December 17, 2009
Last Updated
January 18, 2014
Sponsor
Faculdade de Medicina do ABC
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1. Study Identification

Unique Protocol Identification Number
NCT01052844
Brief Title
Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy
Official Title
Clinical Trial of Gabapentin in the Prevention of Nausea Ond Vomiting Induced by Chemotherapy, a Randomized, Double-blind, Placebo Controled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Medicina do ABC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy induced emesis. The purpose of this study is to determine whether the addition of gabapentin to dexamethasone plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.
Detailed Description
This was a prospective, double-blind, placebo-controlled study conducted at our institution (Faculdade de Medicina da Fundação ABC and affiliated Hospitals) from April 2009 to April 2010. Patients and personnel involved in the study were blinded to the assigned treatment. The study was approved by the ethics committee of our institution. All the patients provided written informed consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Cisplatin Adverse Reaction
Keywords
Vomiting, Antiemetics, Dexamethasone, Cisplatin, Antineoplastic combined chemotherapy protocols

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Gabapentin 300mg: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, given orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 300mg, orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)
Primary Outcome Measure Information:
Title
Number of Patients With Complete Response During Chemotherapy Course 1
Description
The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)
Time Frame
5 days
Title
Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1
Description
Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First course of chemotherapy ( cisplatin or doxorubicin at a dose of at least 50mg per square meter) Written informed consent must be obtained before initiating the protocol procedures Exclusion Criteria: ECOG 3 Nausea and vomiting within the past 1 day Gastrointestinal obstruction Concurrent use of opioid Patients with brain metastases History of allergic or other adverse reaction to gabapentin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Auro del Giglio, phD
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Study Director
Facility Information:
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21465325
Citation
Cruz FM, de Iracema Gomes Cubero D, Taranto P, Lerner T, Lera AT, da Costa Miranda M, da Cunha Vieira M, de Souza Fede AB, Schindler F, Carrasco MM, de Afonseca SO, Pinczowski H, del Giglio A. Gabapentin for the prevention of chemotherapy- induced nausea and vomiting: a pilot study. Support Care Cancer. 2012 Mar;20(3):601-6. doi: 10.1007/s00520-011-1138-4. Epub 2011 Apr 5.
Results Reference
derived

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Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

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