Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin
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|ClinicalTrials.gov Identifier: NCT00729677|
Recruitment Status : Completed
First Posted : August 7, 2008
Results First Posted : March 18, 2011
Last Update Posted : October 26, 2015
RATIONALE: Learning how often patients experience nausea and vomiting after receiving anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better treatment and improve patients' quality of life.
PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-vomiting medicine during the first course of chemotherapy.
|Condition or disease|
|Colorectal Cancer Nausea Vomiting|
- To assess the prevalence of delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-emetic medications during the first course of an oxaliplatin-based chemotherapy regimen (mFOLFOX6 or FOLFOX7).
OUTLINE: This is a multicenter study.
Patients undergo collection of demographic, diagnostic, and treatment data at baseline. Patients complete the Functional Living Index-Emesis (FLIE) questionnaire at baseline prior to first chemotherapy infusion and at 5-7 days. Patients also fill out daily patient diaries about symptoms of nausea and vomiting, and use of medications to prevent these symptoms over days 1-5.
|Study Type :||Observational|
|Actual Enrollment :||64 participants|
|Official Title:||Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||December 2008|
- Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy [ Time Frame: Week 1 of FOLFOX chemotherapy ]
- 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 ]Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.
- Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy [ Time Frame: week 1 ]Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy
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): NCT00729677
|United States, New York|
|Beth Israel Medical Center - Philipps Ambulatory Care Center|
|New York, New York, United States, 10003|
|Principal Investigator:||Stewart Barry Fleishman, MD||Beth Israel Medical Center|