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 sites88 target enrollmentNovember 19, 2012

ConditionsCancer

Overview

Registry

who.int

Start Date

November 19, 2012

End Date

December 29, 2015

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Sponsor

Southampton University Hospitals NHS Trust (UK)

•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)