Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00880191
First received: April 10, 2009
Last updated: July 3, 2015
Last verified: July 2015
Results First Received: April 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: dexamethasone
Drug: gabapentin
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
430 patients were enrolled on this study. There are 17 cancelled patients, 7 on the gabapentin arm and 10 on the placebo arm.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gabapentin

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.

> dexamethasone: Given orally

> gabapentin: Given orally

Placebo

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.

> dexamethasone: Given orally

> placebo: Given orally


Participant Flow:   Overall Study
    Gabapentin     Placebo  
STARTED     207     206  
Available for Primary Endpoint Analysis     207     206  
COMPLETED     194     198  
NOT COMPLETED     13     8  
Refused further treatment                 4                 1  
Adverse Event                 8                 6  
Hospitalization/efficacy                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gabapentin 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. > dexamethasone: Given orally > gabapentin: Given orally
Placebo 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. > dexamethasone: Given orally > placebo: Given orally
Total Total of all reporting groups

Baseline Measures
    Gabapentin     Placebo     Total  
Number of Participants  
[units: participants]
  207     206     413  
Age, Customized  
[units: participants]
     
<50 Years     57     58     115  
>=50 Years     150     148     298  
Gender  
[units: participants]
     
Female     145     145     290  
Male     62     61     123  
Region of Enrollment  
[units: participants]
     
United States     207     206     413  



  Outcome Measures
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1.  Primary:   Comparison of Percentage of Complete Responders   [ Time Frame: Days 2 through 6 ]

2.  Secondary:   Complete Response   [ Time Frame: Days 2-6 ]

3.  Secondary:   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 ]

4.  Secondary:   Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents   [ Time Frame: Days1 through 6 ]

5.  Secondary:   Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses   [ Time Frame: Days 1 through 6 ]

6.  Secondary:   Level of Satisfaction for the Control of Nausea.   [ Time Frame: Days 1 through 6 ]

7.  Secondary:   Comparison of Daily Complete Response Endpoints   [ Time Frame: Days 1 through 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Debra L. Barton RN, PhD, AOCN
Organization: Mayo Clinic
phone: 507/284-1623
e-mail: barton.debra@mayo.edu


No publications provided


Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00880191     History of Changes
Other Study ID Numbers: NCCTG-N08C3, NCI-2009-01110, CDR0000634077
Study First Received: April 10, 2009
Results First Received: April 13, 2015
Last Updated: July 3, 2015
Health Authority: United States: Federal Government