Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer

Conditions
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Colorectal Cancer, Nausea, Vomiting

Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of colorectal cancer Currently receiving OR scheduled to receive the first course of either of the following chemotherapy regimens: mFOLFOX6 FOLFOX7 No clinical or imaging evidence of brain metastasis PATIENT CHARACTERISTICS: Able to maintain a diary and complete a standardized quality of life questionnaire in English PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 90 days since prior aprepitant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Week 1 | 
| Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy | 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 | week 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea and vomiting, colon cancer, rectal cancer