The Protective Effect of Ginkgo Biloba Extract on Cisplatin-induced Ototoxicity in Humans

University of Brasilia

Status and phase: Completed; Phase 2

Conditions: Hearing Loss; Ototoxicity

Treatments: Drug: Placebo; Drug: Ginkgo Biloba Extract (GBE761)

Study type: Interventional

Funder types: Other

Identifiers

NCT01139281

CEPSESDF-024-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

Study Group

Active Comparator group

Description:

The Study Group(SG) received Ginkgo biloba extract(GBE761)(240mg/day)plus cisplatin(CDDP)

Treatment:

Drug: Ginkgo Biloba Extract (GBE761)

Control Group(CG)

Placebo Comparator group

Description:

The Control Group received Placebo plus CDDP

Treatment:

Drug: Placebo