Hearing Loss Clinical Trial
Official title:
Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?
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.
Status | Not yet recruiting |
Enrollment | 110 |
Est. completion date | February 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: 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 - Cerebrovascular haemorrhage - Acute gout - Hypersensitivity to NSAIDs |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hearing loss | before and after chemotherapy | No | |
Secondary | hearing loss and tinnitus questionnaires | before and after cisplatin treatment | No |
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