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Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Standard Anti-Vomiting Medicine During the First Course of Chemotherapy
This study has been completed.
Sponsored by: Beth Israel Medical Center - Philipps Ambulatory Care Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00729677
  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 Intervention
Colorectal Cancer
Nausea and Vomiting
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: assessment of therapy complications
Procedure: nausea and vomiting therapy
Procedure: quality-of-life assessment
Procedure: questionnaire administration

MedlinePlus related topics: Cancer Colorectal Cancer Nausea and Vomiting
Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Oxaliplatin Calcium gluconate
U.S. FDA Resources
Study Type: Observational
Official Title: Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-Based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Presence and degree of nausea and vomiting in the acute and delayed phases after oxaliplatin-based chemotherapy as recorded in the patient's diary over days 1-5 [ Designated as safety issue: Yes ]
  • Impact of nausea and vomiting on the patient's quality of life as measured by the Functional Living Index - Emesis scale at baseline and at 5-7 days [ Designated as safety issue: Yes ]
  • Comparison of this study's findings with those from aprepitant-containing anti-emetic studies conducted with cisplatin-containing regimens [ Designated as safety issue: No ]
  • Investigation of potential factors predisposing patients to nausea and vomiting (e.g., gender, age, prior chemotherapy experience, or tendency toward development of motion-sickness) [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2005
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
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
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 - Philipps Ambulatory Care Center
Investigators
Principal Investigator: Stewart Barry Fleishman, MD Beth Israel Medical Center - Philipps Ambulatory Care Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Beth Israel Medical Center - Philipps Ambulatory Care Center ( Stewart Barry Fleishman )
Study ID Numbers: CDR0000599895, BIMCP-NV-SURVEY, BIMCP-IRB-37-04, MERCK-BIMCP-NV-SURVEY
Study First Received: August 6, 2008
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00729677  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
nausea and vomiting
colon cancer
rectal cancer

Study placed in the following topic categories:
Vomiting
Digestive System Neoplasms
Signs and Symptoms, Digestive
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm
Calcium, Dietary
Signs and Symptoms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Nausea
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 13, 2009