Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Julia Abab


Contact details

Southampton University Hospitals NHS Trust
Clinical Trials Unit
MailPoint 816
Tremona Road
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

2012-001509-25 number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

The COAST study aims to recruit 88 cisplatin-naïve patients who will be undergoing high dose cisplatin treatment for malignancy in order to assess whether aspirin can reduce hearing loss in this group of patients. Approximately 18,500 patients receive Cisplatin on an annual basis within the UK and 50% of the patients receiving a high dose regimen have a significant reduction in hearing loss following treatment which is both permanent and irreversible. As Cisplatin is usually given with a curative intent the treatment potentially leaves a patient with resulting deafness that results in considerable reduction in Quality of Life. In some patients the hearing loss may be restored by use of hearing aids however in others the hearing loss is so severe that they could only be considered for cochlear implantation. As well as the impact on the quality of life of the patient both hearing aids and cochlear implantation have important short and long term costs to the NHS. The outcome of this research could therefore have important implications both economically and for the quality of life of cancer patients worldwide.

Ethics approval

First MREC, 20/08/2012 ref: 12/SC/0391

Study design

Randomised interventional treatment trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet




1. Aspirin & omeprazole: aspirin 975mg TID, omeprazole 20mg OD
2. Asprin & omeprazole placebos: matching placebos to IMP

Intervention type



Phase II

Drug names

Aspirin, omeprazole

Primary outcome measure

The total difference in hearing measured before and 7 days after treatment

Secondary outcome measures

1. Assessment of compliance and concomitant medications measured during entire study duration
2. Assessment of other PTA test-frequencies measured at 7 days post treatment and 3 months post treatment
3. Cisplatin dose-intensity measured during entire study duration
4. Common Toxicity Criteria (CTC) measured during entire study duration
5. OAE profile measured 7 days after finishing treatment and a further 3 months after finishing treatment
5. Safety profile assessment measured during entire study duration
6. The total difference in hearing measured before and 3 months after treatment

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Participant type


Age group




Target number of participants

UK Sample Size: 88; Description: We have estimated the SD of hearing loss (SD=45) from a sample of 27 people who have been treated with Cisplatin.

Participant exclusion criteria

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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Southampton University Hospitals NHS Trust
SO16 6YD
United Kingdom

Sponsor information


Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Cancer Research UK

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Once approved by Ethics, a letter to patients will be sent to all participating sites. They will then have the opportunity of sending it out to patients if applicable. Further publications are to be confirmed at a later date.

IPD sharing plan
There are no plans to make COAST participant level data available. Any request will need to be sent to the Southampton Clinical Trials Unit Data Release Committee (DRC) and will need to be agreed by both the DRC and Trial Management Group. The data will be held securely by Southampton Clinical Trials unit, maintained in a form that meets business needs and current regulatory requirement and destroyed after the retention period ends.

Intention to publish date

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2017 results in:

Publication citations

Additional files

Editorial Notes

15/02/2018: Publication reference added. 03/01/2017: IPD sharing plan added. 21/11/2016: The overall trial end date was changed from 31/10/2014 to 29/12/2015.