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

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.

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Key information

Conditions

Nausea and Vomiting Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Unspecified Adult Solid Tumor, Protocol Specific Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack University Medical Center, Hackensack, New Jersey, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron

Drug

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Patient Information and Antiemetic Drug Efficacy

Important dates

Study start: 2000
Primary completion: 2001
Study completion: 2001
First posted: Jun 9, 2004
Registry last updated: Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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