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| Sponsors and Collaborators: |
James P. Wilmot Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005994 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ondansetron |
| Study Type: | Interventional |
| Study Design: | Randomized |
| Official Title: | Patient Information and Antiemetic Drug Efficacy |
| Study Start Date: | August 2000 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13210 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Study Chair: | Gary R. Morrow, PhD, MS | James P. Wilmot Cancer Center |
More Information
| Study ID Numbers: | CDR0000067996, URCC-3996, NCI-P00-0160 |
| Study First Received: | July 5, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005994 History of Changes |
| Health Authority: | United States: Federal Government |
|
nausea and vomiting unspecified adult solid tumor, protocol specific |
|
Neurotransmitter Agents Vomiting Tranquilizing Agents Signs and Symptoms, Digestive Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents |
Serotonin Signs and Symptoms Antipruritics Anti-Anxiety Agents Nausea Ondansetron Peripheral Nervous System Agents |
|
Neurotransmitter Agents Tranquilizing Agents Vomiting Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Antipsychotic Agents Pharmacologic Actions |
Signs and Symptoms Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Antipruritics Anti-Anxiety Agents Nausea Ondansetron Peripheral Nervous System Agents Dermatologic Agents Central Nervous System Agents |
