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Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00729677
First received: August 6, 2008
Last updated: March 16, 2011
Last verified: March 2011
  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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Stewart Barry Fleishman, Beth Israel Medical Center - Philipps Ambulatory Care 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
Study First Received: August 6, 2008
Results First Received: September 15, 2009
Last Updated: March 16, 2011
Health Authority: United States: Federal Government

Keywords provided by Beth Israel Medical Center:
nausea and vomiting
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Nausea
Vomiting
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Oxaliplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014