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NCT Number: NCT01052844

Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

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.

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Key information

Conditions

Vomiting Cisplatin Adverse Reaction Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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)

Gabapentin

Drug

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 outcomes

  1. Number of Patients With Complete Response During Chemotherapy Course 1

    Time frame: 5 days

    The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)

  2. Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1

    Time frame: 6 days

    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

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Registry information

Official study title

Clinical Trial of Gabapentin in the Prevention of Nausea Ond Vomiting Induced by Chemotherapy, a Randomized, Double-blind, Placebo Controled Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 20, 2010
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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