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Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Completed

Conditions

Vomiting
Nausea
Colorectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT00729677
BIMCP-IRB-37-04
BIMCP-NV-SURVEY
MERCK-BIMCP-NV-SURVEY
237-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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