Patient Education in Preventing Nausea and Vomiting in Cancer Patients Receiving Chemotherapy

Not Applicable

Completed

• Conditions: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00005994
• Lead Sponsor: University of Rochester

Brief Summary

RATIONALE: Patient education may improve the effectiveness of ondansetron in preventing nausea and vomiting in patients receiving chemotherapy.

PURPOSE: This randomized clinical trial is studying how well patient education works in preventing nausea and vomiting in cancer patients receiving chemotherapy.

Detailed Description

OBJECTIVES: I. Determine whether an educational intervention to enhance the effectiveness of ondansetron can prevent acute postchemotherapy nausea and emesis in cancer patients. II. Assess any potential effectiveness of the intervention on delayed postchemotherapy nausea and emesis in these patients. III. Examine the effect of the intervention on patient expectations.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by center and chemotherapy agent (cisplatin vs carboplatin vs doxorubicin). Patients are randomized to one of two treatment arms. Arm I: Patients receive standard educational materials. Arm II: Patients receive specific intervention material in addition to standard educational materials. Patients then complete a patient information questionnaire. Patients receive ondansetron orally or IV over 10-15 minutes in addition to the first 2 courses of chemotherapy. Patients complete a nausea and emesis questionnaire after each of their first 2 chemotherapy treatments.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

Study Timeline

• Study First Submitted: 2000-07-05
• Study Start: 2000-08
• Primary Completion: 2001-07
• Study Completion: 2001-07
• Study First Submitted QC: 2004-06-08
• Study First Posted: 2004-06-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

University of Rochester Cancer Center; 🇺🇸 Rochester, New York, United States

CCOP - Southeast Cancer Control Consortium; 🇺🇸 Winston-Salem, North Carolina, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.; 🇺🇸 Syracuse, New York, United States