COAST - Cisplatin Ototoxicity attenuated by Aspirin TrialA randomised, Phase II, double-blind, placebo-controlled, two arm Trial to establish whether Aspirin can reduce hearing loss/ototoxicity for patients receiving Cisplatin chemotherapy. - COAST - Cisplatin Ototoxicity attenuated by Aspirin Trial

niversity Hospital Southampton NHS Foundation Trust0 sites94 target enrollmentAugust 10, 2012

Overview

No summary available.

Registry

who.int

Start Date

August 10, 2012

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospital Southampton NHS Foundation Trust

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 0
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 0

•1\.Previous Cisplatin treatment.
•2\.Patients with a diagnosis of Nasopharyngeal (or skull base) Carcinoma.Patients with other head and neck tumours being treated with radiotherapy are eligible.
•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 Haemorrhagic stroke.
•6\.Inflammatory bowel disease.
•7\.Patients with absolute contraindications to Aspirin, PPIs or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants.
•8\.Haematological or clotting disorders.
•9\.Patients with symptomatically overt hearing loss which the principal investigator considers should exclude the use of cisplatin.
•10\.Pregnant or breast\-feeding 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.