Aprepitant in the Prevention of Delayed Emesis Induced by Moderately Emetogenic Chemotherapy (Cyclophosphamide Plus Anthracyclines) in Breast Cancer Patients: a Double-blind Randomized Study
18 Years
N/A
Female
Emesis
Trial Information
Aprepitant in the Prevention of Delayed Emesis Induced by Moderately Emetogenic Chemotherapy (Cyclophosphamide Plus Anthracyclines) in Breast Cancer Patients: a Double-blind Randomized Study
This is a phase III, double-blind, randomized trial, to evaluated the efficacy and safety of
aprepitant for the prevention of delayed emesis in patients with breast cancer submitted for
the first time to chemotherapy with cyclophosphamide plus anthracyclines.
The study will be carried out during the first cycle of chemotherapy.
For the prevention of acute emesis, all patients will receive, before chemotherapy:
- dexamethasone 8 mg iv in 15 minutes, 30 minutes before chemotherapy;
- palonosetron 0.25 mg iv bolus, 30 minutes before chemotherapy
- aprepitant 125 mg orally, 60 minutes before chemotherapy
After 24 hours from chemotherapy administration, patients will be randomized to receive:
A) 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.
B) Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3.
The patients will receive prochlorperazine suppositories as rescue medication, for important
nausea and vomiting (> 2 episodes) during days 1-5 after chemotherapy.
The patients will receive a diary, which includes a Visual Analogue Scale (VAS) for nausea
and vomiting evaluation. All patients will fill out the diary in which, for 6 consecutive
days (days 1-6), patients will report for each day the number of vomiting episodes, the
intensity and duration of nausea, any antiemetic rescue medication and any adverse event
and its treatment.
In addition, on day 1 before chemotherapy and then on day 6, patients will fill out the
FLIE (Functional Living Index-Emesis), a questionnaire concerning the impact of nausea and
vomiting on their quality of life.
Primary end point is the percentage of complete responses (no vomiting and no rescue
treatment) on days 2-5 after chemotherapy administration
Inclusion Criteria:
- patients with breast cancer, receiving for the first time chemotherapy with
cyclophosphamide + anthracyclines (FAC, FEC, AC, EC).
- patients over 18 years old and those who signed informed consent
- adequate contraception if premenopausal women
Every other anticancer drug in the first 24 hours will be administered after the end of
cyclophosphamide plus anthracycline.
Exclusion Criteria:
- patients already submitted to chemotherapy
- patients receiving any chemotherapy on days 2-4 after treatment
- patients with concomitant severe diseases or with predisposition to emesis such as
intestinal obstruction, active peptic ulcer, hypercalcemia and brain metastases
- contraindications to corticosteroids (i.e., active peptic ulcer or previous bleeding
from peptic ulcer
- patients submitted to concomitant radiotherapy or submitted to radiotherapy in the 15
days before chemotherapy or planned to receive radiotherapy during the 8 days after
chemotherapy
- patients receiving other concomitant antiemetic treatments or submitted to antiemetic
treatments in the 24 hours before chemotherapy
- patients with nausea or vomiting in the 24 hours before chemotherapy
- patients receiving concomitant steroids, except when administered at physiologic
doses
- patients receiving concomitant benzodiazepines, except when used for nocturnal
sedation
- patients with WBC count <3000/mm3 or platelet count <70000/mm3
- patients who are pregnant or breast-feeding
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration
Outcome Time Frame:
6 days
Safety Issue:
Yes
Principal Investigator
Fausto Roila, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Oncology Division, S. Maria Hospital, Terni, Italy
Authority:
Italy: Ministry of Health
Study ID:
IGAR-02-2009
NCT ID:
NCT00869973
Start Date:
September 2009
Completion Date:
July 2012
Related Keywords:
- Emesis
- aprepitant
- delayed emesis
- cyclophosphamide plus anthracyclines
- breast cancer
- antiemetic
- Breast Neoplasms
- Vomiting
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