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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT00005994
First received: July 5, 2000
Last updated: March 4, 2013
Last verified: March 2013
  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: Allocation: Randomized
Official Title: Patient Information and Antiemetic Drug Efficacy

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Study Start Date: August 2000
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005994

Locations
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
University of Rochester Cancer Center
Rochester, New York, United States, 14642
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13210
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Sponsors and Collaborators
University of Rochester
Investigators
Study Chair: Gary R. Morrow, PhD, MS James P. Wilmot Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Gary Morrow, Director, URCC CCOP Research Base, University of Rochester
ClinicalTrials.gov Identifier: NCT00005994     History of Changes
Other Study ID Numbers: CDR0000067996, URCC-3996, NCI-P00-0160
Study First Received: July 5, 2000
Last Updated: March 4, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
nausea and vomiting
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Antiemetics
Ondansetron
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on July 23, 2014