Patient Education in Preventing Nausea and Vomiting in Cancer Patients Receiving Chemotherapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: ondansetron (Drug); nausea and vomiting therapy (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: James P. Wilmot Cancer Center Official(s) and/or principal investigator(s):
Gary R. Morrow, PhD, MS, Study Chair, Affiliation: James P. Wilmot Cancer Center
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.
Clinical Details
Official title: Patient Information and Antiemetic Drug Efficacy
Study design: Other, Randomized
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
specified
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Locations and Contacts
Hackensack University Medical Center, Hackensack, New Jersey 07601, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13210, United States
University of Rochester Cancer Center, Rochester, New York 14642, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 2000
Last updated: October 25, 2007
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