Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?

NCT00578760 | Unknown

• 1 other identifier: Aspirin-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Ototoxicity

Keywords

hearing loss; ototoxicity; cisplatin

Outcome Measures

Primary Outcomes (1)

• hearing loss

  before and after chemotherapy

Secondary Outcomes (1)

• hearing loss and tinnitus questionnaires

  before and after cisplatin treatment

Study Arms (2)

2

PLACEBO COMPARATOR

placebo OD during course of chemotherapy

Drug: placebo

1

EXPERIMENTAL

325mg ASA OD during course of chemotherapy

Drug: aspirin

Interventions

aspirin DRUG

325mg ASA OD for the duration of the cisplatin

1

placebo DRUG

OD for course of cisplatin chemotherapy

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Hearing Loss; Ototoxicity

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Emma Barker, FRCS, PhD

CONTACT

001-416-946-4501; emmabarker@doctors.org.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 21, 2007
• Study Start: February 1, 2008
• Study Completion: February 1, 2010
• Last Updated: December 21, 2007

Record last verified: 2007-12

Locations

CA (1)