Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00729677

Recruitment Status : Completed

First Posted : August 7, 2008

Results First Posted : March 18, 2011

Last Update Posted : October 26, 2015

Sponsor:

Information provided by (Responsible Party):

Beth Israel Medical Center

Study Description

Brief 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.

Condition or disease
Colorectal Cancer Nausea Vomiting

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.

Study Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	64 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer
Study Start Date :	June 2005
Actual Primary Completion Date :	November 2008
Actual Study Completion Date :	December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nausea and Vomiting

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome 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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients receiveing chemotherapy including oxaliplatin at the ambulatory care center

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729677

Locations

Layout table for location information

United States, New York
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, United States, 10003

Sponsors and Collaborators

Beth Israel Medical Center

Investigators

Layout table for investigator information

Principal Investigator:	Stewart Barry Fleishman, MD	Beth Israel Medical Center

More Information

Layout table for additonal information

Responsible Party:	Beth Israel Medical Center
ClinicalTrials.gov Identifier:	NCT00729677
Other Study ID Numbers:	237-04 BIMCP-NV-SURVEY BIMCP-IRB-37-04 MERCK-BIMCP-NV-SURVEY
First Posted:	August 7, 2008 Key Record Dates
Results First Posted:	March 18, 2011
Last Update Posted:	October 26, 2015
Last Verified:	October 2015

Keywords provided by Beth Israel Medical Center:


nausea and vomiting colon cancer rectal cancer

Additional relevant MeSH terms:

Layout table for MeSH terms

Colorectal Neoplasms Nausea Vomiting Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site	Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms, Digestive

To Top