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Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer

NCT00343863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-07-11

Study results available
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Summary

RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron hydrochloride, and palonosetron hydrochloride, may help lessen or prevent nausea and vomiting caused by chemotherapy.

PURPOSE: This clinical trial studies how well giving dexamethasone together with ondansetron hydrochloride or palonosetron hydrochloride works in preventing nausea and vomiting in patients receiving doxorubicin hydrochloride and cyclophosphamide for early stage breast cancer

Conditions

  • Male Breast Cancer
  • Nausea and Vomiting
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer

Interventions

DRUG

palonosetron hydrochloride

Given IV

DRUG

cyclophosphamide

Given orally

DRUG

dexamethasone

Given orally or IV

DRUG

doxorubicin hydrochloride

Given IV

PROCEDURE

quality-of-life assessment

Ancillary studies

PROCEDURE

nausea and vomiting therapy

Given IV

PROCEDURE

management of therapy complications

Given IV

DRUG

ondansetron hydrochloride

Given IV

OTHER

survey administration

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Hannah Linden · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00343863 on ClinicalTrials.gov