Cisplatin Ototoxicity attenuated by ASpirin Trial (COAST)

ISRCTN	ISRCTN83689269
DOI	https://doi.org/10.1186/ISRCTN83689269
EudraCT/CTIS number	2012-001509-25
Secondary identifying numbers	13400

Submission date: 19/11/2012
Registration date: 19/11/2012
Last edited: 15/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-to-see-if-aspirin-can-reduce-hearing-loss-caused-by-cisplatin-coast

Contact information

Ms Julia Abab
Scientific

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

Email	J.Abab@soton.ac.uk

Study information

Study design	Randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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 acronym	COAST
Study objectives	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(s)	First MREC, 20/08/2012 ref: 12/SC/0391
Health condition(s) or problem(s) studied	Cancer
Intervention	1. Aspirin & omeprazole: aspirin 975mg TID, omeprazole 20mg OD 2. Asprin & omeprazole placebos: matching placebos to IMP
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	31/10/2012
Completion date	29/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	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.
Key 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
Key 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
Date of first enrolment	31/10/2012
Date of final enrolment	31/10/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southampton University Hospitals NHS Trust

Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Website	http://www.uhs.nhs.uk/
"ROR"	https://ror.org/0485axj58

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2017		Yes	No
HRA research summary			28/06/2023	No	No

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.