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Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy

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ClinicalTrials.gov Identifier: NCT00880191
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : May 21, 2015
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:

RATIONALE: Gabapentin may prevent or reduce delayed nausea and vomiting caused by chemotherapy. It is not yet known whether gabapentin is more effective than a placebo in preventing nausea and vomiting.

PURPOSE: This randomized phase III trial is studying the side effects of gabapentin and to see how well it works compared with a placebo in preventing nausea and vomiting in patients receiving chemotherapy.


Condition or disease Intervention/treatment Phase
Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific Drug: dexamethasone Drug: gabapentin Other: placebo Phase 3

Detailed Description:

OBJECTIVES:

  • To evaluate the effectiveness of gabapentin in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy as defined by the percentage of complete responders (no emetic episodes and no rescue medication) on days 2 through 6 (five days after receipt of highly emetogenic chemotherapy) compared to an effective prophylactic regimen.
  • To evaluate the effectiveness of gabapentin in controlling delayed CINV in patients receiving highly emetogenic chemotherapy as defined by the percentage of complete responders (no emetic episodes, no more than mild nausea, and no rescue medication) on days 2 through 6 compared to an effective prophylactic regimen.
  • To compare the effectiveness of these regimens in controlling acute CINV on day 1 of treatment in these patients.
  • To compare the use of rescue agents in these patients.
  • To determine the tolerability of gabapentin in these patients.
  • To evaluate the effect of gabapentin for delayed chemotherapy-induced nausea and vomiting on symptom distress and functional abilities in these patients.
  • To compare alternative endpoints and methods for assessing nausea and vomiting and to determine how these measures compare to patient's satisfaction with symptom control, distress and function.

OUTLINE: This is a multicenter study. Patients are stratified according to gender, age (< 50 years vs > 50 years), history of alcoholism (yes vs no), and history of motion sickness or history of pregnancy induced nausea/vomiting (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
  • Arm II: Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.

Patients complete a Functional Living Index - Emesis questionnaire, an overall satisfaction survey, and a side effect experience diary at baseline and on day 6. Patients also complete a nausea and vomiting diary at baseline and periodically during study therapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patients Receiving Highly Emetogenic Chemotherapy
Study Start Date : April 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
 Drug: dexamethasone
Given orally

Drug: gabapentin
Given orally
Experimental: Arm II
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
 Drug: dexamethasone
Given orally

Other: placebo
Given orally


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of Percentage of Complete Responders [ Time Frame: Days 2 through 6 ]
    Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.


Secondary Outcome Measures :
  1. Complete Response [ Time Frame: Days 2-6 ]
    The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents.

  2. Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6. [ Time Frame: Days 1 through 6 ]
    The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.

  3. Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents [ Time Frame: Days1 through 6 ]
    The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups.

  4. Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses [ Time Frame: Days 1 through 6 ]
    The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared.

  5. Level of Satisfaction for the Control of Nausea. [ Time Frame: Days 1 through 6 ]
    Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index - Emesis (FLIE) questionnaire ( 1-7 scale, lower the better)

  6. Comparison of Daily Complete Response Endpoints [ Time Frame: Days 1 through 6 ]
    Daily complete response is defined as no emetic episodes and no use of rescue therapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Scheduled to receive highly emetogenic chemotherapy

    • May be scheduled to receive prophylactic treatment for acute nausea and vomiting with a 5HT3 antagonist and dexamethasone 20 mg on day 1 of chemotherapy treatment
    • May be scheduled to receive multiple day chemotherapy regimens as long as the chemotherapy drugs given on the subsequent days have mild or no emetogenic potential
  • Chemotherapy schedules must allow at least 7 days rest between courses involving administration of highly emetogenic chemotherapy
  • No primary CNS malignancy and/or CNS metastasis

PATIENT CHARACTERISTICS:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy ≥ 3 months
  • Creatinine ≤ 1.5 times upper limit of normal within the past 30 days
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Ability to complete questionnaire(s) by his/herself or with assistance
  • Able to swallow pills
  • No epilepsy or seizure history
  • No gastrointestinal obstruction, active peptic ulcer disease, or uncontrolled heartburn
  • No history of nausea and/or vomiting related to any kind of chemotherapy
  • No nausea or vomiting within the past 3 days
  • No history of allergic or other adverse reaction to gabapentin or pregabalin

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior moderate or highly emetogenic chemotherapy
  • No prior or concurrent aprepitant or any other NK-1 receptor antagonist
  • At least 1 months since prior and no concurrent gabapentin, pregabalin, or other anticonvulsants
  • At least 7 days since prior and no concurrent pelvic or abdominal radiotherapy
  • At least 3 days since prior antiemetics
  • No concurrent or planned use of lorazepam, diphenhydramine, eszopiclone, and/or dronabinol during the 6 days of this study, except for treatment of breakthrough nausea and vomiting
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880191


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
More Information
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00880191    
Other Study ID Numbers: NCCTG-N08C3
NCI-2009-01110 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000634077 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 13, 2009    Key Record Dates
Results First Posted: May 21, 2015
Last Update Posted: July 6, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
nausea and vomiting
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Gabapentin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics
Sensory System Agents
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents