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A trial to see if aspirin can reduce hearing loss caused by cisplatin (COAST)

This is a trial to see if taking aspirin can reduce hearing loss caused by chemotherapy that includes the drug cisplatin. The trial is supported by Cancer Research UK.

Cisplatin is a chemotherapy drug that doctors use to treat different types of cancer. Unfortunately, cisplatin can cause some hearing loss. This happens to some degree in about half the people who have cisplatin.

We know from laboratory research that aspirin may be able to reduce hearing loss caused by cisplatin. But doctors want to find out for certain if it helps.

The aim of this trial is to see if taking aspirin each time you have cisplatin helps to reduce hearing loss.

Recruitment

Start 18/12/2012
End 01/10/2014

Phase

Phase 2

Who can enter

You may be able to enter this trial if you

  • Are going to have cisplatin as part of your cancer treatment
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have had cisplatin in the past
  • Have nasopharyngeal cancer (you can take part if you have another type of head and neck cancer and are having radiotherapy)
  • Are going to have treatment where the dose of cisplatin is split and you have it for more than 2 days in a row, or at different times in a cycle of treatment (your doctor can confirm this)
  • Are taking part in another clinical trial
  • Are already taking aspirin unless the dose is 75mg a day or lower
  • Have had a stroke
  • Have inflammatory bowel disease
  • Can’t take aspirin or drugs called proton pump inhibitors, such as omeprazole
  • Have certain blood disorders or blood clotting problems
  • Already have hearing loss and the trial team think you shouldn't have cisplatin
  • Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit 88 people who are going to have chemotherapy with cisplatin.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.  And neither of you will know which group you are in either. This is called a double blind trial.

People in one group take aspirin and a tablet called omeprazole. The omeprazole helps to reduce the risk of aspirin irritating your stomach lining.

People in the other group take 2 dummy tablets (placebos).

You take the tablets for 4 or 5 days each time you have cisplatin. The trial team will tell you exactly how and when to take the tablets.

You have cisplatin through a drip into a vein. Most people have cisplatin up to 6 times.

The trial team will ask you to keep a diary during your treatment. In this, you note down when you take your tablets and whether you are sick at any time.

Everybody taking part will have the opportunity to have 2 different  hearing tests

  • Before they start chemotherapy
  • In the week following their last chemotherapy treatment
  • 3 months after finishing treatment

The first test is a standard hearing test that measures your ability to hear at different volumes and pitches. This is called a pure tone audiogram or PTA.

The second test is called an otoacoustic emissions (OAE) test. (This is pronounced ot-oh-ak-oo-stik.) It is similar to the test used to measure hearing in new born babies. You have a small probe placed against your ear for a few seconds. The probe contains a microphone and a speaker. Sounds are generated in the probe and the responses that come back from your ear are recorded.

The OAE test can only be carried out at Southampton. If you are having your treatment elsewhere, you can choose only to have the PTA test which will be carried out locally. Or, if you wish to travel to Southampton you can have both the PTA and OAE hearing tests at the Royal South Hants Hospital.

Hospital visits

You have an extra hospital visit before you start chemotherapy to collect your trial tablets.

You have the hearing tests 3 times all together. It takes about half an hour each time to have both tests.

After each chemotherapy treatment, a research nurse will contact you by phone to see if you had any side effects. This will take less than 5 minutes each time. They may also phone you before your next treatment to remind you to take your tablets. And they will phone you at the end of treatment to make sure you are well enough to have your next hearing tests.

Side effects

The side effects of aspirin are usually mild and don’t happen very often, but can include

  • Ringing in your ears (tinnitus) – this stops when you stop taking the aspirin
  • Irritation of the stomach lining
  • Bleeding from the stomach lining (this is rare)

Taking omeprazole reduces the risk of stomach irritation or bleeding, and the researchers think as you only take aspirin for a short period of time in this trial, it is unlikely to cause either problem.

The side effects of omeprazole include

  • Headache
  • Diarrhoea or constipation
  • Stomach ache
  • Feeling or being sick

But again, taking it for a short time is unlikely to cause problems.

Location of trial

  • Birmingham
  • Bournemouth
  • Cardiff
  • Kingston upon Thames
  • Leeds
  • London
  • Poole
  • Southampton
  • Sutton

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Dr Emma King

This is Cancer Research UK trial number CRUK/11/047.

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
University of Southampton
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Updated: 14 July 2014