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| Sponsor: | Beth Israel Medical Center |
|---|---|
| Information provided by: | Beth Israel Medical Center |
| ClinicalTrials.gov Identifier: | NCT00729677 |
Purpose
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 |
|---|
|
Colorectal Cancer Nausea Vomiting |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer |
| Enrollment: | 64 |
| Study Start Date: | June 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients receiveing chemotherapy including oxaliplatin at the ambulatory care center
DISEASE CHARACTERISTICS:
Currently receiving OR scheduled to receive the first course of either of the following chemotherapy regimens:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| 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 |
More Information
| 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 |
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nausea and vomiting colon cancer rectal cancer |
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Colorectal Neoplasms Nausea Vomiting Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms, Digestive Signs and Symptoms Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |