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Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin
This study has been completed.
Study NCT00729677   Information provided by Beth Israel Medical Center

First Received on August 6, 2008.   Last Updated on March 16, 2011   History of Changes
Results First Received: September 15, 2009  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Colorectal Cancer
Nausea
Vomiting

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The original intent had been to analyze data on 100 chemotherapy cycles in 100 subjects. Instead, in order to accelerate accrual, we analyzed data on 1 cycle in 24 subjects and 2 cycles in 40 subjects.

Reporting Groups
  Description
Patients With Colorectal Cancer Starting Chemotherapy patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.

Participant Flow:   Overall Study
    Patients With Colorectal Cancer Starting Chemotherapy  
STARTED     64  
COMPLETED     64  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Patients With Colorectal Cancer Starting Chemotherapy patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.

Baseline Measures
    Patients With Colorectal Cancer Starting Chemotherapy  
Number of Participants  
[units: participants]
  64  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     38  
>=65 years     26  
Gender  
[units: participants]
 
Female     30  
Male     34  
Region of Enrollment  
[units: participants]
 
United States     64  



  Outcome Measures
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1.  Primary:   Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy   [ Time Frame: Week 1 of FOLFOX chemotherapy ]

2.  Primary:   Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index – Emesis Scale at 5-7 Days   [ Time Frame: Week 1 ]

3.  Primary:   Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy   [ Time Frame: week 1 ]

4.  Post-Hoc:   Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy   [ Time Frame: Week 1 ]


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
This was a convenience sample of patients seen at 2 medical centers. Subjects were restricted to those who could complete Quality of Life forms in Spanish or English.  


Results Point of Contact:  
Name/Title: Victoria Rosenwald, RN MPH
Organization: Beth Israel Cancer Center
phone: 212 844-8285
e-mail: vrosenwa@chpnet.org


No publications provided


Responsible Party: Stewart Barry Fleishman, Beth Israel Medical Center - Philipps Ambulatory Care Center
ClinicalTrials.gov Identifier: NCT00729677     History of Changes
Other Study ID Numbers: 237-04, BIMCP-NV-SURVEY, BIMCP-IRB-37-04, MERCK-BIMCP-NV-SURVEY
Study First Received: August 6, 2008
Results First Received: September 15, 2009
Last Updated: March 16, 2011
Health Authority: United States: Federal Government