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Patient Information and Antiemetic Drug Efficacy

18 Years
Not Enrolling
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

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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

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

Inclusion Criteria

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

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized

Principal Investigator

Gary R. Morrow, PhD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2000

Completion Date:

July 2001

Related Keywords:

  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • nausea and vomiting
  • unspecified adult solid tumor, protocol specific
  • Nausea
  • Vomiting



University of Rochester Cancer Center Rochester, New York  14642
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Hackensack University Medical Center Hackensack, New Jersey  07601