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Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study

This study has been terminated.
(Study was stopped due to inadequate accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183481
First Posted: August 17, 2010
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
Dr. Edward Chow, Sunnybrook Health Sciences Centre
Results First Submitted: June 24, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Nausea
Vomiting
Interventions: Drug: Aprepitant
Radiation: Palliative radiation therapy
Drug: Granisetron

  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
Patients were enrolled between January 2011 and October 2012 in a radiation oncology clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No enrolled patients were later excluded.

Reporting Groups
  Description
Aprepitant and Granisetron Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.

Participant Flow:   Overall Study
    Aprepitant and Granisetron
STARTED   19 
COMPLETED   19 
NOT COMPLETED   0 



  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
Aprepitant and Granisetron Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.

Baseline Measures
   Aprepitant and Granisetron 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   13 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.4  (15.48) 
Gender 
[Units: Participants]
 
Female   11 
Male   8 
Region of Enrollment 
[Units: Participants]
 
Canada   19 


  Outcome Measures
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1.  Primary:   The Proportion of Patients Experiencing no Vomiting and no Nausea, Without Use of Any Rescue Antiemetic Medication(s), From Days 2-10 Following the Radiation Therapy (Delayed RINV).   [ Time Frame: Days 2-10 following radiotherapy ]

2.  Secondary:   Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy   [ Time Frame: Day of radiotherapy and 24 hours following ]

3.  Secondary:   Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy   [ Time Frame: Days 2-10 following radiotherapy ]

4.  Secondary:   Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy   [ Time Frame: During radiotherapy (5 days) and the 24 hours following radiotherapy ]

5.  Secondary:   Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy   [ Time Frame: Days 2-10 following radiotherapy ]

6.  Secondary:   The Complete RINV Prophylaxis Rate (Acute and Delayed Phases), the Partial Emesis Control Rate, the Safety of the Combined Regime, QOL Issues, the Time to the First Emetic Event and Use of Rescue Medication .   [ Time Frame: From day of radiotherapy to 10 days following radiotherapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Small number of subjects results in early termination of study


  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: Dr. Edward Chow
Organization: Sunnybrook Health Sciences Centre
phone: 416-480-4998
e-mail: edward.chow@sunnybrook.ca



Responsible Party: Dr. Edward Chow, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01183481     History of Changes
Other Study ID Numbers: RINV Prophylaxis
First Submitted: August 4, 2010
First Posted: August 17, 2010
Results First Submitted: June 24, 2013
Results First Posted: January 20, 2014
Last Update Posted: December 5, 2014