|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Beth Israel Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| 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 | Intervention |
|---|---|
|
Colorectal Cancer Nausea and Vomiting |
Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Other: questionnaire administration Procedure: assessment of therapy complications Procedure: nausea and vomiting therapy Procedure: quality-of-life assessment |
| 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.
Eligibility| 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:
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: | 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: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00729677 History of Changes |
| Health Authority: | United States: Federal Government |
|
nausea and vomiting colon cancer rectal cancer |
|
Antimetabolites Vomiting Antimetabolites, Antineoplastic Immunologic Factors Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Colonic Diseases Leucovorin Rectal Diseases Signs and Symptoms Oxaliplatin Neoplasms by Site |
Vitamins Therapeutic Uses Nausea Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms |