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.
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
- Are there results?
- None posted in the registry
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.
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.
- Conditions
- Hearing Loss, Ototoxicity
- 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 group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | placebo OD during course of chemotherapy Receives: Drug: placebo |
| 1 | Experimental | 325mg 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.
hearing loss
Measured: before and after chemotherapy
Secondary outcomes (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.
- First posted21 Dec 2007 (estimated)
- Study startFeb 2008
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?
- ClinicalTrials.gov ID
- NCT00578760
- Acronym / sponsor ID
- Aspirin-01
- Conditions
- Hearing Loss, Ototoxicity
- Keywords
- hearing loss, ototoxicity, cisplatin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2008
- Study completion
- Feb 2010 (estimated)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: placeboplacebo OD during course of chemotherapy |
| 1 | Experimental | Drug: aspirin325mg ASA OD during course of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients undergoing cisplatin treatment for the following malignancies:
- Over 18 years of age
- Normal otoscopic examination
- Informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin325mg ASA OD for the duration of the cisplatin | Drug | 1 |
| placeboOD for course of cisplatin chemotherapy | Drug | 2 |
Primary outcome
hearing loss
Time frame: before and after chemotherapy
1 secondary outcome
hearing loss and tinnitus questionnaires
Time frame: before and after cisplatin treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aspirin in people with Hearing Loss and Ototoxicity, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Barker, FRCS, PhD (001-416-946-4501 ext. 4353, emmabarker@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing loss (time frame: before and after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007.