COAST - Cisplatin Ototoxicity attenuated by Aspirin Trial

• Research type

  Research Study

• Full title

  COAST - Cisplatin Ototoxicity attenuated by Aspirin Trial 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.

• IRAS ID

  91162

• Contact name

  Emma King

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Eudract number

  2012-001509-25

• ISRCTN Number

  n/a

• Research summary

  Approximately half of all patients receiving Cisplatin chemotherapy to treat their cancer will develop some degree of hearing loss due to a side-effect of their chemotherapy. At the moment, although we think that Aspirin may reduce hearing loss when used with Cisplatin, we do not know for certain. To find out, we need to compare two different treatment groups. Group 1 will receive Aspirin together with Omeprazole (which helps with any gastric side effects of the Aspirin) and group 2 will receive placebo's in place of Aspirin and Omeprazole. Neither the patients nor the hospital staff will know which arm patients are randomised to. Patients will be put into groups randomly by a computer. Both before and after their course of treatment, patients' hearing will be tested to see if there is a difference in hearing loss between the two groups.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  12/SC/0391

• Date of REC Opinion

  20 Aug 2012

• REC opinion

  Further Information Favourable Opinion