Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Medical Center - Philipps Ambulatory Care Center

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Aug 7, 2008
Registry last updated: Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed