Trial Name:
COAST - Cisplatin Ototoxicity attenuated by ASpirin Trial
Description:
A placebo controlled study to gather initial information on whether aspirin reduces hearing loss/ototoxicity for patients receiving cisplatin chemotherapy.
Objectives:
Primary Objective:
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To establish whether aspirin can reduce hearing loss/ototoxicity for patients receiving cisplatin based chemotherapy.
Secondary Objectives:
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To determine whether it is feasible to conduct a Phase III randomised controlled Trial of aspirin for the same patient population.
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To quantify the extent of hearing loss in patients receiving cisplatin via the use of otoacoustic emissions (OAE).
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To determine whether patients are able to tolerate short-term, large doses of enteric-coated aspirin taken with omeprazole without significant side-effects and with no loss of cisplatin dose-intensity.
Design:
Randomised, Phase II, double-blind, placebo-controlled, two arm Trial.
Status:
Completed
Population:
39 patients over 18 years of age in each arm deemed fit for chemotherapy according to sites own local defined cancer network protocol for chemotherapy regimes.
Publications:
COAST (Cisplatin ototoxicity attenuated by aspirin trial): A phase II double-blind, randomised controlled trial to establish if aspirin reduces cisplatin induced hearing-loss
Contact details:
All Trial enquiries should be addressed to
[email protected]