Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

Beth Israel Medical Center64 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer Nausea Vomiting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Medical Center - Philipps Ambulatory Care Center

New York, New York, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Week 1

Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy

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

Time frame: week 1

Data from ClinicalTrials.gov

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