Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felipe Melo Cruz, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT01052844
First received: December 17, 2009
Last updated: January 18, 2014
Last verified: January 2014
  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 Adverse Reaction
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:


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

Primary Outcome Measures:
  • Number of Patients With Complete Response During Chemotherapy Course 1 [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
    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


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

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 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)
Experimental: Gabapentin

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 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)

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052844

Locations
Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil, 09060-650
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, MsC, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT01052844     History of Changes
Other Study ID Numbers: ABC-2009
Study First Received: December 17, 2009
Results First Received: September 24, 2010
Last Updated: January 18, 2014
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 September 30, 2014