Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer
18 Years
N/A
Both
Colorectal Cancer, Nausea, Vomiting
Trial Information
Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy
Outcome Time Frame:
Week 1 of FOLFOX chemotherapy
Safety Issue:
No
Principal Investigator
Stewart Barry Fleishman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beth Israel Medical Center
Authority:
United States: Federal Government
Study ID:
237-04
NCT ID:
NCT00729677
Start Date:
June 2005
Completion Date:
December 2008
Related Keywords:
- Colorectal Cancer
- Nausea
- Vomiting
- nausea and vomiting
- colon cancer
- rectal cancer
- Colorectal Neoplasms
- Nausea
- Vomiting
Name | Location |
|---|---|
| Beth Israel Medical Center - Philipps Ambulatory Care Center | New York, New York 10003 |
