ÉTUDE PILOTE OBSERVATIONNELLE CHEZ DES PATIENTES SOUFFRANT D’UN CANCER DU SEIN ET RECEVANT UNE CHIMIOTHÉRAPIE ÉMÉTISANTE TRAITÉES PAR UNE DOSE UNIQUE DE ALOXI® (PALONOSÉTRON) 0,25 MG ASSOCIÉE À UNE CORTICOTHÉRAPIE

THERABEL LUCIEN PHARMA0 个研究点目标入组 250 人开始时间: 2007年1月12日最近更新: 2014年10月7日

试验速览

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•- Age > 18 years
•- Patients with non-metastatic breast cancer (cytologically or histologically confirmed) and who are to receive a 1st course of adjuvant chemotherapy on D1
•- Patients must receive one of the three following chemotherapy regimens, all of those being fully administrated at Day 1 (D1) every 3 (or 4) weeks (there shall not be any chemotherapy administration in the meantime between V1 and V2):
•a) 5-FU (500 mg/m2) + Epirubicin (75 or 100 mg/m2) + Cyclophosphamide (500 mg/m² ): FEC (75 or 100)
•b) Epirubicin (75 mg/m²) + Cyclophosphamide (> 500 mg/m²): EC
•c) Adriamycin (40 or 50 mg/m²) + Cyclophosphamide (> 500 mg/m²): AC
•- Patients who have given their informed consent in writing
•- Karnofsky performance status > 60
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Pregnant or breastfeeding female
•- Vomiting events (or retching) or nausea on the day of inclusion or in the 24 hours preceding the day of inclusion
•- Female suffering from alcoholism or drug dependency
•- Patients included in a clinical trial in the previous month
•- Patients whose language ability or ability to understand could negatively affect the proper completion of the self-evaluation diary.
•- Prior treatment with palonosetron
•- Contraindication to methylprednisolone (SPC of SOLUMEDROL®, Appendices § 14.7)
•- An ongoing cancer chemotherapy other than that which is allowed in the inclusion criteria of the protocol
•- Administration in the 24 hours prior to inclusion or on the day of the inclusion of any of the following medicinal products:
•a) Other ‘setrons’ (ondansetron, granisetron, tropisetron, dolasetron)
•b) Metoclopramide, phenothiazine (perphenazine), scopolamine, diphenhydramine, chlorphenamine, benzodiazepines (except for temazepam or triazolam used as a single dose as a hypnotic), haloperidol, droperidol, tetrahydrocannabinol
•c) Corticosteroid therapy (except for topical and inhaled preparations, which are allowed)
•- Hypersensitivity to the active substance or any of the excipients

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