Plain English Summary
Trial website
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
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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
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.
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
Results - basic reporting
Publication summary