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

Patient Information and Antiemetic Drug Efficacy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005994
Enrollment
Unknown
Registered
2004-06-09
Start date
2000-08-31
Completion date
2001-07-31
Last updated
2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

nausea and vomiting, unspecified adult solid tumor, protocol specific

Brief 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.

Interventions

DRUGondansetron

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026