Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729677
• Other study ID #: 237-04
• Secondary ID: BIMCP-NV-SURVEYB
• Status: Completed
• Phase: N/A
• First received: August 6, 2008
• Last updated: October 5, 2015
• Start date: June 2005
• Est. completion date: December 2008

Study information

• Verified date: October 2015
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Nausea
• Vomiting

Locations

Country	Name	City	State
United States	Beth Israel Medical Center - Philipps Ambulatory Care Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy		Week 1 of FOLFOX chemotherapy	No
Primary	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.	Week 1	No
Primary	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	week 1	No