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

This study has been completed.
Sponsor:
Information provided by:
University of Brasilia
ClinicalTrials.gov Identifier:
NCT01139281
First received: June 1, 2010
Last updated: June 7, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Ototoxicity
Hearing Loss
 Drug: Ginkgo Biloba Extract (GBE761)
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Protective Effect of Ginkgo Biloba Extract on Cisplatin-Induced Ototoxicity in Humans Beings Evaluated by Distortion Product Otoacoustic Emissions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Brasilia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study Group
The Study Group(SG) received Ginkgo biloba extract(GBE761)(240mg/day)plus cisplatin(CDDP)
 Drug: Ginkgo Biloba Extract (GBE761)
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 Name: Study Group
Placebo Comparator: Control Group(CG)
The Control Group received Placebo plus CDDP
 Drug: Placebo
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 Name: Control Group

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139281

Locations
Brazil
Hospital de Base do Distrito Federal (HBDF)
Brasília, DF, Brazil, 70000-000
Sponsors and Collaborators
University of Brasilia
Investigators
Principal Investigator: Mirela A Dias University of Brasília
Study Chair: Carlos CP Oliveira University of Brasília
  More Information

Publications:

Responsible Party: Mirela Alves Dias, University of Brasilia - Medical School
ClinicalTrials.gov Identifier: NCT01139281     History of Changes
Other Study ID Numbers: CEPSESDF-024-07
Study First Received: June 1, 2010
Last Updated: June 7, 2010
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Brasilia:
Ear protection
Ginkgo Biloba Extract
Distortion-product otoacoustic emission
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
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013