Trial Information

Patient Information and Antiemetic Drug Efficacy

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.