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Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

NCT00475085 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1021

Last updated 2015-11-10

Study results available
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Summary

RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy.

PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.

Conditions

Interventions

DRUG

aprepitant

Given orally or IV

DRUG

dexamethasone

Given orally or IV

DRUG

granisetron hydrochloride

Given orally or IV

DRUG

palonosetron hydrochloride

Given orally or IV

DRUG

prochlorperazine

Given orally or IV

DRUG

placebo

Given orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Joseph Roscoe

    lead OTHER

Principal Investigators

  • Joseph A. Roscoe, PhD · James P. Wilmot Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00475085 on ClinicalTrials.gov