Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin


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.

Full Title of Study: “Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2008

Detailed Description

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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy
    • Time Frame: Week 1 of FOLFOX chemotherapy
  • Impact of Nausea and Vomiting on the Patient’s Quality of Life as Measured by the Functional Living Index – Emesis Scale at 5-7 Days
    • Time Frame: Week 1
    • Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.
  • Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy
    • Time Frame: week 1
    • Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy

Participating in This Clinical Trial


  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beth Israel Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stewart Barry Fleishman, MD, Principal Investigator, Beth Israel Medical Center

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