NCT00005994

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

Patient Information and Antiemetic Drug Efficacy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nausea and Vomiting
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	ondansetron

Timeline

• Start date: 2000-08-01
• Primary completion: 2001-07-01
• Completion: 2001-07-01
• First posted: 2004-06-09
• Last updated: 2013-03-05

Locations

4 sites across 1 country: United States