NCT00005994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2000

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2000

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2000

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

June 9, 2004

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

11 months

First QC Date

July 5, 2000

Last Update Submit

March 4, 2013

Conditions

Nausea and VomitingUnspecified Adult Solid Tumor, Protocol Specific

Keywords

nausea and vomitingunspecified adult solid tumor, protocol specific

Interventions

ondansetronDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13210, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

MeSH Terms

Conditions

NauseaVomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Gary R. Morrow, PhD, MS

    James P. Wilmot Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, URCC CCOP Research Base

Study Record Dates

First Submitted

July 5, 2000

First Posted

June 9, 2004

Study Start

August 1, 2000

Primary Completion

July 1, 2001

Study Completion

July 1, 2001

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

US(4)