Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients

NCT00869973 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2013-01-23

No results posted yet for this study

Summary

The aim of the study is to compare efficacy and tolerability of aprepitant versus dexamethasone in the prevention of delayed emesis induced by moderately emetogenic chemotherapy (cyclophosphamide plus anthracyclines) in breast cancer patients.

Conditions

  • Emesis

Interventions

DRUG

Aprepitant

Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3

DRUG

dexamethasone

dexamethasone 4 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on day 3

Sponsors & Collaborators

  • S. Maria Hospital, Terni

    lead OTHER

Principal Investigators

  • Fausto Roila, MD · Oncology Division, S. Maria Hospital, Terni, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Italy

Study Locations

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Entities

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 NCT00869973 on ClinicalTrials.gov