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| Tracking Information | |||||
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| First Received Date ICMJE | August 6, 2008 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00729677 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Standard Anti-Vomiting Medicine During the First Course of Chemotherapy | ||||
| Official Title ICMJE | Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-Based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer | ||||
| 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | |||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00729677 | ||||
| Responsible Party | Stewart Barry Fleishman, Beth Israel Medical Center - Philipps Ambulatory Care Center | ||||
| Study ID Numbers ICMJE | CDR0000599895, BIMCP-NV-SURVEY, BIMCP-IRB-37-04, MERCK-BIMCP-NV-SURVEY | ||||
| Study Sponsor ICMJE | Beth Israel Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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