AzTrials
AzTrials

Hearing LossNCT00578760

Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?

A study testing aspirin in people with Hearing Loss and Ototoxicity, run by University Health Network, Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Aspirin (ASA) has been shown, in an animal model, to attenuate the ototoxic properties of cisplatin. The researchers plan to investigate this in patients undergoing cisplatin chemotherapy. The researchers hypothesise that low-dose aspirin can prevent cisplatin induced ototoxicity in the clinical setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Loss, Ototoxicity
What is being tested?
aspirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteCanada
Study dates
Feb 2008to Feb 2010
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing cisplatin treatment for the following malignancies:
  • germ-cell
  • bladder
  • head and neck (Only head and neck patients requiring only 2 cycles of post-operative chemo-radiotherapy, and therefore not requiring a gastrostomy tube, will be enrolled.)
  • Over 18 years of age
  • Normal otoscopic examination
  • Informed consent

Who cannot join

  • Patients with the following will be excluded:
  • Not able to grasp the study implications or unable to consent.
  • History of peptic ulcer disease
  • Severe renal impairment (U\&E, Cr clearance)
  • Haemophilia
  • Severe hepatic impairment
Show all 9Show fewer
  • Cerebrovascular haemorrhage
  • Acute gout
  • Hypersensitivity to NSAIDs

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Princess Margaret Hospital

    Toronto, Ontario

    Emma Barker, FRCS, PhD

Other trials in Canada

About this study

Aspirin (ASA) has been shown, in an animal model, to attenuate the ototoxic properties of cisplatin. The researchers plan to investigate this in patients undergoing cisplatin chemotherapy.

The researchers hypothesise that low-dose aspirin can prevent cisplatin induced ototoxicity in the clinical setting.

Read the detailed description

Cisplatin has the highest ototoxic potential of all platinum containing compounds. It is used in the treatment of squamous cell carcinoma of the head and neck, germ cell tumours of the testis and bladder carcinoma.

42% of 400 patients receiving high-dose cisplatin (70-85 mg/m2, median cumulative dose 420mg) experienced common toxicity criteria (CTC: appendix 1) grade 3 or 4 symptoms (De Jongh 2003). Ototoxicity is dose related: 75-100% of patients receiving a very high dose and 20-40% with a low dose regime will develop significant ototoxic symptoms. In one study, 50% of head and neck cancer patients treated with cisplatin develop ototoxicity (Blakley 1994).

Cisplatin ototoxicity can present as a variable collection of symptoms and signs. These include bilateral and symmetrical hearing loss that is permanent and irreversible. High frequency sensorineural hearing loss with progression towards lower frequencies. Tinnitus, that is also permanent and irreversible.

There are a number of known factors that can predispose to cisplatin ototoxicity. They include: Dose, duration and mode of administration, age extremes, previous or concurrent cranial irradiation, previous history of hearing loss, renal disease, concomitant use of other ototoxic drugs, noise exposure with concomitant cisplatin administration, decreased serum albumin level, low hemoglobin level, low red blood cell count and a low haematocrit. Interestingly, cisplatin ototoxicity is considered to be exclusively confined to the cochlear, the vestibular system is unaffected (Myers 1993).

Ototoxicity from chemotherapeutic agents is due, in part, to reactive oxygen species. Reactive oxygen species can be attenuated by antioxidants. Salicylates are antioxidants that can be administered as aspirin.

It has been shown, in an animal model, that aspirin can protect hearing from cisplatin induced ototoxicity (Li 2002). In this set of experiments, the rat was used to evaluate the protective role of aspirin in both the acute and chronic setting. Auditory evoked brain stem responses were used to determine pre- and post-intervention hearing thresholds. In the acute experiments (n=23), one dose of cisplatin (16mg/kg) was administered and the animals were given aspirin (100mg/kg) starting the day before cisplatin treatment and continuing 4 days thereafter. There was a significant difference in hearing thresholds between the treatment and control groups at 3, 8 and 14kHz.

In the chronic experiments cisplatin was given on days 1, 4 and 7 (5mg/kg). Aspirin was given from 2 days before to 3 days after cisplatin treatment (100mg/kg bd). The hearing thresholds were compared before the first dose and 10 days after the last treatment. In those animals treated concurrently with aspirin, their hearing did not differ form control animals at 16 and 24 kHz. This was correlated to a significant reduction in inner hair cell loss from 20% (cisplatin) to 8% (cisplatin and aspirin).

Salicylates also protected renal function as determined by both plasma blood urea nitrogen and creatinine levels.

Salicylates did not affect tumour mass or metastasis. The rats were inoculated with malignant breast cancer cells (metastatic mammary adenocarcinoma). Aspirin protected against cisplatin-induced ototoxicity, without affecting the oncolytic action of the cisplatin.

Gentamicin and cisplatin both have a similar ototoxic mechanism of action. Aspirin has been shown to prevent gentamicin-induced hearing loss without compromising its anti-bacterial efficacy in both animal models and the clinical setting (Sha 2006, Chen 2007). Sha's group reported a prospective, randomized, double-blind trial with 200 patients. The patients all required gentamycin for clinical indications. In the 'treatment' arm of the study, the patients also received aspirin (1g tds for 14 days). A significant difference in hearing was shown at 6 and 8kHz of >15dB if aspirin was not given.

Being tested
aspirin, placebo
Keywords
hearing loss, ototoxicity, cisplatin
Medical subject headings
Hearing Loss, Ototoxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aspirinDrug

    325mg ASA OD for the duration of the cisplatin

  • placeboDrug

    OD for course of cisplatin chemotherapy

Study groups in NCT00578760
Study groupRoleWhat they receive
2Placebo comparatorplacebo OD during course of chemotherapy
Receives: Drug: placebo
1Experimental325mg ASA OD during course of chemotherapy
Receives: Drug: aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hearing loss

    Measured: before and after chemotherapy

Secondary outcomes (1)
  1. hearing loss and tinnitus questionnaires

    Measured: before and after cisplatin treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2007 (estimated)
  2. Study startFeb 2008
  3. Study completionFeb 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00578760
Sponsor's protocol ID
Aspirin-01
Status last verified
Dec 2007
First submitted
18 Dec 2007
Last updated
21 Dec 2007
Results posted
No
Data monitoring committee
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in