A randomised, phase II, double-blind, placebo-controlled, two-arm trial to establish whether aspirin can reduce hearing loss/ototoxicity for patients receiving cisplatin chemotherapy

Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 88 人开始时间: 2012年11月19日最近更新: 2018年3月19日

适应症

试验速览

•1. Written informed consent
•2. Any patient deemed fit for chemotherapy with acceptable laboratory values and offered a cumulative dose equal to or more than 200mg/m2 Cisplatin as a single agent or as a combination chemotherapy for malignancy with planned treatment of a maximum of two consecutive days Cisplatin per cycle
•3. Over 18 years old
•4. Male or female

•1. Previous cisplatin treatment
•2. Patients with a diagnosis of Nasopharyngeal (or skull base) Carcinoma
•3. Patients where planned Cisplatin is to be given as a split dose regimen on Days 1 to 5 or on Days 1 and 8
•4. Patients receiving therapeutic Aspirin defined as >75mg per day
•5. Previous transient ischaemic attacks or cerebral vascular disease
•6. Severe ischaemic heart disease or myocardial infarction in the previous 6 months
•7. Inflammatory bowel disease
•8. Patients with absolute contraindications to Aspirin, PPIs or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants
•9. Haematological or clotting disorders
•10. Patients with pre-existing sensorineural hearing loss (>40dB at the standard audiometric frequencies (0.5 8 inclusive) in their worst hearing ear)
•11. Pregnant or breastfeeding patients. Women of childbearing potential must have a standard negative pregnancy test performed within 7days prior to the start of Trial drug. Both men and women enrolled in this Trial must use adequate birth control
•12. Patients enrolled or who plan to enrol in any other IMP or Surgical Interventional Clinical Trial during the Trial period

发起方

Southampton University Hospitals NHS Trust (UK)