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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration
Fausto Roila, MD
Oncology Division, S. Maria Hospital, Terni, Italy
Italy: Ministry of Health