We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01139281
First Posted: June 8, 2010
Last Update Posted: June 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Brasilia
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 1, 2010
First Posted: June 8, 2010
Last Update Posted: June 8, 2010
Last Verified: May 2010

Keywords provided by University of Brasilia:
Ear protection
Ginkgo Biloba Extract
Distortion-product otoacoustic emission
Ototoxicity
Cisplatin

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cisplatin
Antineoplastic Agents