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Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729677
First Posted: August 7, 2008
Last Update Posted: October 26, 2015
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.
Information provided by (Responsible Party):
Beth Israel Medical Center
  Purpose

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
Colorectal Cancer Nausea Vomiting

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

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


Enrollment: 64
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Principal Investigator: Stewart Barry Fleishman, MD Beth Israel Medical Center
  More Information

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00729677     History of Changes
Other Study ID Numbers: 237-04
BIMCP-NV-SURVEY
BIMCP-IRB-37-04
MERCK-BIMCP-NV-SURVEY
First Submitted: August 6, 2008
First Posted: August 7, 2008
Results First Submitted: September 15, 2009
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:
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
Signs and Symptoms
Oxaliplatin
Antineoplastic Agents