Condition category
Cancer
Date applied
19/11/2012
Date assigned
19/11/2012
Last edited
21/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Julia Abab

ORCID ID

Contact details

Southampton University Hospitals NHS Trust
Clinical Trials Unit
MailPoint 816
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
J.Abab@soton.ac.uk

Additional identifiers

EudraCT number

2012-001509-25

ClinicalTrials.gov number

Protocol/serial number

13400

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.

Acronym

COAST

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Cancer

Intervention

1. Aspirin & Omeprazole: Aspirin 975mg TID, Omeprazole 20mg OD
2. Asprin & Omeprazole Placebos: Matching placebos to IMP

Intervention type

Drug

Phase

Phase II

Drug names

Aspirin, omeprazole

Primary outcome measures

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

31/10/2012

Overall trial end date

29/12/2015

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

31/10/2012

Recruitment end date

31/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhs.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/11/2016: the overall trial end date was changed from 31/10/2014 to 29/12/2015.