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

June 7, 2010 updated by: University of Brasilia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • DF
      • Brasília, DF, Brazil, 70000-000
        • Hospital de Base do Distrito Federal (HBDF)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
the patients were followed about ninety days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Investigators

  • Principal Investigator: Mirela A Dias, University of Brasilia
  • Study Chair: Carlos CP Oliveira, University of Brasilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (ESTIMATE)

June 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2010

Last Update Submitted That Met QC Criteria

June 7, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPSESDF-024-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Loss

Clinical Trials on Ginkgo Biloba Extract (GBE761)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe