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Completed

NCT Number: NCT01139281

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital de Base do Distrito Federal (HBDF)

Brasília, Federal District, 70000-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginkgo Biloba Extract (GBE761)

Drug

The subjects were randomized and allocated in two groups: Control Group(CG) and Study Group(SG). the study group received GBE761(120mg twice a day) plus cisplatin and was guided to ingest GBE761 just before initial cisplatin dosage. The maximum cumulative cisplatin dosage was 300mg/m². They were followed up for ninety days. Comparisons were made between baseline distortion-product otoacoustic emissions measurements and those DPOAE records after maximum cumulative cisplatin dosage.

Other names: Study Group

Placebo

Drug

The subjects were randomized and allocated in two groups: control group and study group. The control group received placebo plus cisplatin and was guided to ingest Placebo just before initial cisplatin dosage. The maximum cumulative cisplatin dosage was 300mg/m². They were followed up for ninety days. Comparisons were made between baseline distortion-product otoacoustic emissions measurements and those DPOAE records after maximum cumulative cisplatin dosage.

Other names: Control Group

Primary outcomes

  1. 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.

    Time frame: the patients were followed about ninety days

    The protective effect of GBE761 on CDDP induced ototoxicity in human beings was evaluated with DPOAE mean amplitudes and signal-to-noise ratio (SNR) values at in the frequencies ranging from 1 to 8KHz in the study and control groups, between before and after cumulative CDDP injections, in order to evaluate the significant differences in DPOAE results, and so to differentiate hearing status ( normal hearing or hearing loss) while the subjects were taking GBE or placebo.

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study title

The Protective Effect of Ginkgo Biloba Extract on Cisplatin-Induced Ototoxicity in Humans Beings Evaluated by Distortion Product Otoacoustic Emissions

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 8, 2010
Registry last updated
Jun 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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