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Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Standard Anti-Vomiting Medicine During the First Course of Chemotherapy
This study has been completed.
Study NCT00729677   Information provided by National Cancer Institute (NCI)
First Received: August 6, 2008   Last Updated: February 6, 2009   History of Changes

August 6, 2008
February 6, 2009
June 2005
November 2008   (final data collection date for primary outcome measure)
  • Presence and degree of nausea and vomiting in the acute and delayed phases after oxaliplatin-based chemotherapy as recorded in the patient's diary over days 1-5 [ Designated as safety issue: Yes ]
  • Impact of nausea and vomiting on the patient's quality of life as measured by the Functional Living Index - Emesis scale at baseline and at 5-7 days [ Designated as safety issue: Yes ]
  • Comparison of this study's findings with those from aprepitant-containing anti-emetic studies conducted with cisplatin-containing regimens [ Designated as safety issue: No ]
  • Investigation of potential factors predisposing patients to nausea and vomiting (e.g., gender, age, prior chemotherapy experience, or tendency toward development of motion-sickness) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00729677 on ClinicalTrials.gov Archive Site
 
 
 
Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Standard Anti-Vomiting Medicine During the First Course of Chemotherapy
Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-Based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer

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.

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.

 
Observational
 
  • 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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
100
 
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00729677
Stewart Barry Fleishman, Beth Israel Medical Center - Philipps Ambulatory Care Center
CDR0000599895, BIMCP-NV-SURVEY, BIMCP-IRB-37-04, MERCK-BIMCP-NV-SURVEY
Beth Israel Medical Center
 
Principal Investigator: Stewart Barry Fleishman, MD Beth Israel Medical Center
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP