Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University Health Network, Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00578760
First received: December 18, 2007
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

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 Intervention
Hearing Loss
Ototoxicity
Drug: aspirin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • hearing loss [ Time Frame: before and after chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hearing loss and tinnitus questionnaires [ Time Frame: before and after cisplatin treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578760

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

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

No publications provided

Responsible Party: Dr John Rutka, UNH
ClinicalTrials.gov Identifier: NCT00578760     History of Changes
Other Study ID Numbers: Aspirin-01
Study First Received: December 18, 2007
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University Health Network, Toronto:
hearing loss
ototoxicity
cisplatin

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

ClinicalTrials.gov processed this record on August 21, 2014