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Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Faculdade de Medicina do ABC.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT01052844
First received: December 17, 2009
Last updated: January 19, 2010
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Vomiting
Cisplatin
Antineoplastic Combined Chemotherapy Protocols
 Drug: Placebo
Drug: Gabapentin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of Gabapentin in the Prevention of Nausea Ond Vomiting Induced by Chemotherapy, a Randomized, Double-blind, Placebo Controled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Faculdade de Medicina do ABC:

Primary Outcome Measures:
  • Proportional of patients with complete response (CR) during chemotherapy course 1 (0-120h). The CR will be defined as no emetic episodes and no nausea episodes. [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • Proportion of patients with CR during acute phase (0-24 hours) after administration of chemotherapy course 1 [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • Proportion of patients with CR during delayed-onset phase (24-120 hours) after administration of chemotherapy course 1 [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life and the impact of nausea and vomiting on day 6 with the nausea subscale on the Functional Living Index-emesis questionnaire [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Time to treatment failure based on time to first emetic episode or time to first use of rescue medication [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Severity of nausea daily and during chemotherapy course 1 (0-120 hours) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group

Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)

Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy

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
Placebo, given orally
Experimental: Gabapentin

Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)

Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy

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
Gabapentin 300mg, orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052844

Contacts
Contact: Felipe M Cruz 551181388214 felipemcruz@yahoo.com.br
Contact: Elie Fiss 551149935427 fmabc@fmabc.br

Locations
Brazil
Faculdade de Medicina do ABC Recruiting
Santo André, São Paulo, Brazil, 09060-650
Contact: Helio Pinczowski     55114993-5491     cepho@cepho.org.br    
Sponsors and Collaborators
Faculdade de Medicina do ABC
Investigators
Study Director: Auro del Giglio, phD Faculdade de Medicina do ABC
  More Information

No publications provided by Faculdade de Medicina do ABC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Felipe Melo Cruz, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT01052844     History of Changes
Other Study ID Numbers: ABC-2009
Study First Received: December 17, 2009
Last Updated: January 19, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade de Medicina do ABC:
Vomiting
Antiemetics
Dexamethasone
Cisplatin
Antineoplastic combined chemotherapy protocols

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Gabapentin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics
Sensory System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on June 18, 2013