NCT01052844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

March 7, 2014

Completed
Last Updated

March 7, 2014

Status Verified

January 1, 2014

Enrollment Period

1.5 years

First QC Date

December 17, 2009

Results QC Date

September 24, 2010

Last Update Submit

January 18, 2014

Conditions

VomitingCisplatin Adverse Reaction

Keywords

VomitingAntiemeticsDexamethasoneCisplatinAntineoplastic combined chemotherapy protocols

Outcome Measures

Primary Outcomes (2)

  • 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)

    5 days

  • 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

    6 days

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Gabapentin

EXPERIMENTAL

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

Drug: Gabapentin

Interventions

PlaceboDRUG

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)

Control group
GabapentinDRUG

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)

Gabapentin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 21465325DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Felipe Melo Cruz
Organization
Faculdade de Medicina do ABC
felipemcruz@yahoo.com.br
+55+11+27595914

Study Officials

  • Auro del Giglio, phD

    Faculdade de Medicina do ABC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC

Study Record Dates

First Submitted

December 17, 2009

First Posted

January 20, 2010

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

March 7, 2014

Results First Posted

March 7, 2014

Record last verified: 2014-01

Locations

BR(1)