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Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?

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ClinicalTrials.gov Identifier: NCT00578760
Recruitment Status : Unknown
Verified December 2007 by University Health Network, Toronto.
Recruitment status was:  Not yet recruiting
First Posted : December 21, 2007
Last Update Posted : December 21, 2007
Information provided by:
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment
Hearing Loss Ototoxicity Drug: aspirin Drug: placebo

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?
Study Start Date : February 2008
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 2
placebo OD during course of chemotherapy
Drug: placebo
OD for course of cisplatin chemotherapy
Experimental: 1
325mg ASA OD during course of chemotherapy
Drug: aspirin
325mg ASA OD for the duration of the cisplatin

Primary Outcome Measures :
  1. hearing loss [ Time Frame: before and after chemotherapy ]

Secondary Outcome Measures :
  1. hearing loss and tinnitus questionnaires [ Time Frame: before and after cisplatin treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578760

Contact: Emma Barker, FRCS, PhD 001-416-946-4501 ext 4353 emmabarker@doctors.org.uk

Canada, Ontario
Princess Margaret Hospital Not yet recruiting
Toronto, Ontario, Canada
Sub-Investigator: Emma Barker, FRCS, PhD         
Sponsors and Collaborators
University Health Network, Toronto

Responsible Party: Dr John Rutka, UNH
ClinicalTrials.gov Identifier: NCT00578760     History of Changes
Other Study ID Numbers: Aspirin-01
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by University Health Network, Toronto:
hearing loss

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors