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Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Nausea, Vomiting

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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 CenterNew York, New York  10003