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Sponsored by: |
Beth Israel Medical Center - Philipps Ambulatory Care Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00729677 |
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 | Intervention |
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Colorectal Cancer Nausea and Vomiting |
Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: assessment of therapy complications Procedure: nausea and vomiting therapy Procedure: quality-of-life assessment Procedure: questionnaire administration |
Study Type: | Observational |
Official Title: | Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-Based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | June 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Currently receiving OR scheduled to receive the first course of either of the following chemotherapy regimens:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 - Philipps Ambulatory Care Center |
Responsible Party: | Beth Israel Medical Center - Philipps Ambulatory Care Center ( Stewart Barry Fleishman ) |
Study ID Numbers: | CDR0000599895, BIMCP-NV-SURVEY, BIMCP-IRB-37-04, MERCK-BIMCP-NV-SURVEY |
Study First Received: | August 6, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00729677 |
Health Authority: | United States: Federal Government |
nausea and vomiting colon cancer rectal cancer |
Vomiting Digestive System Neoplasms Signs and Symptoms, Digestive Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Rectal neoplasm Calcium, Dietary Signs and Symptoms Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Nausea Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients |