Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin
- Conditions
- Colorectal CancerVomitingNausea
- Registration Number
- NCT00729677
- Lead Sponsor
- Beth Israel Medical Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy 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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beth Israel Medical Center - Philipps Ambulatory Care Center
🇺🇸New York, New York, United States