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
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 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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