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Randomized Study of the Efficacy of Patient Information in Alleviating Nausea and Emesis in Cancer Patients Receiving Chemotherapy (Summary Last Modified 01/2001)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Educational/Counseling/Training Closed 18 and over NCI URCC-3996
NCI-P00-0160, NCT00005994

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.

Entry Criteria

Disease Characteristics:


Chemotherapy naive with diagnosis of any cancer scheduled to receive
chemotherapy containing cisplatin, carboplatin, or doxorubicin

Prior/Concurrent Therapy:


See Disease Characteristics

Patient Characteristics:


Age:
 18 and over

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Gary Morrow, PhD, MS, Protocol chair
Ph: 585-275-5513

Registry Information

Official Title		Patient Information and Antiemetic Drug Efficacy

Trial Start Date		2000-08-07

Registered in ClinicalTrials.gov		NCT00005994

Date Submitted to PDQ		2000-05-12

Information Last Verified		2006-11-08

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.