Clinical trial NCT01139281: The Protective Effect of Ginkgo Biloba Extract on Cisplatin-induced Ototoxicity in Humans
Official title: The Protective Effect of Ginkgo Biloba Extract on Cisplatin-Induced Ototoxicity in Humans Beings Evaluated by Distortion Product Otoacoustic Emissions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ototoxicity
Hearing Loss
Keywords: Ear protection
Ginkgo Biloba Extract
Distortion-product otoacoustic emission
Ototoxicity
Cisplatin
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposal of this study was to evaluate in human beings, using distortion product otoacoustic emission (DPOAE) test, the action of ginkgo biloba extract (GBE761)as a possible ear protective against cisplatin (CDDP) induced hearing loss.

Detailed description: The ototoxicity is an alteration caused by drugs that compromises the auditory and vestibular functions. The cisplatin (CDDP) is a potent antineoplastic agent used for the treatment of cancer in both adults and children although it has several side effects. Current opinion is that cisplatin ototoxicity occurs due to alterations in the antioxidant system of the outer hair cells (OHC) of the cochlea. The distortion-product otoacoustic emissions (DPOAE) has been showed to be a sensitive test for diagnosis of OHC injury and has been used for monitoring treatment with ototoxic drugs. Because of their antioxidant properties, the ginkgo biloba extract (GBE761) was evaluated in human beings as a possible ear protective against cisplatin induced hearing loss, using DPOAE test.

Eligibility criteria: Inclusion Criteria:

* Over the age of eighteen
* Patients that will begin treatment with cisplatin
* No prior treatment with cisplatin

Exclusion Criteria:

* Individuals with middle ear, cochlear or retrocochlear disease
* Presence of changes in pure tone audiometry and/or distortion-product otoacoustic emissions

Primary outcomes:
measure: the effect of GBE761 as a possible protector against cisplatin (CDDP) induced hearing loss was evaluated through the DPOAE. Comparisons were made between baseline measurements and those records after maximum cumulative CDDP dosage.
timeFrame: the patients were followed about ninety days
Secondary outcomes:
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Hospital de Base do Distrito Federal (HBDF)
state: DF
Study officials:
affiliation: University of Brasilia
name: Mirela A Dias
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Brasilia
name: Carlos CP Oliveira
role: STUDY_CHAIR
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