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OtotoxicityPhase 2NCT01139281

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

A Phase 2 study testing Ginkgo Biloba Extract (GBE761) in people with Ototoxicity and Hearing Loss, run by University of Brasilia at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ototoxicity, Hearing Loss
What is being tested?
Ginkgo Biloba Extract (GBE761)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteBrazil
Study dates
Jun 2007to Jun 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Over the age of eighteen
  • Patients that will begin treatment with cisplatin
  • No prior treatment with cisplatin

Who cannot join

  • Individuals with middle ear, cochlear or retrocochlear disease
  • Presence of changes in pure tone audiometry and/or distortion-product otoacoustic emissions

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital de Base do Distrito Federal (HBDF)

    Brasília, Federal District, 70000-000

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Ginkgo Biloba Extract (GBE761), Placebo
Keywords
Ear protection, Ginkgo Biloba Extract, Distortion-product otoacoustic emission, Ototoxicity, Cisplatin
Medical subject headings
Ototoxicity, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ginkgo Biloba Extract (GBE761)Drug

    Also called Study Group

    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.

  • PlaceboDrug

    Also called Control Group

    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.

Study groups in NCT01139281
Study groupRoleWhat they receive
Study GroupActive comparatorThe Study Group(SG) received Ginkgo biloba extract(GBE761)(240mg/day)plus cisplatin(CDDP)
Receives: Drug: Ginkgo Biloba Extract (GBE761)
Control Group(CG)Placebo comparatorThe Control Group received Placebo plus CDDP
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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.

    Measured: the patients were followed about ninety days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2010 (estimated)
  2. Study startJun 2007
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01139281
Sponsor's protocol ID
CEPSESDF-024-07
Status last verified
May 2010
First submitted
1 Jun 2010
Last updated
8 Jun 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Biro K, Noszek L, Prekopp P, Nagyivanyi K, Geczi L, Gaudi I, Bodrogi I. Characteristics and risk factors of cisplatin-induced ototoxicity in testicular cancer patients detected by distortion product otoacoustic emission. Oncology. 2006;70(3):177-84. doi: 10.1159/000093776. Epub 2006 Jun 2.

    PubMed 16757924

  • Blakley BW, Myers SF. Patterns of hearing loss resulting from cis-platinum therapy. Otolaryngol Head Neck Surg. 1993 Sep;109(3 Pt 1):385-91. doi: 10.1177/019459989310900302.

    PubMed 8414553

  • Bridi R, Crossetti FP, Steffen VM, Henriques AT. The antioxidant activity of standardized extract of Ginkgo biloba (EGb 761) in rats. Phytother Res. 2001 Aug;15(5):449-51. doi: 10.1002/ptr.814.

    PubMed 11507743

  • Christen Y, Maixent JM. What is Ginkgo biloba extract EGb 761? An overview--from molecular biology to clinical medicine. Cell Mol Biol (Noisy-le-grand). 2002 Sep;48(6):601-11.

    PubMed 12396070

  • Dhooge I, Dhooge C, Geukens S, De Clerck B, De Vel E, Vinck BM. Distortion product otoacoustic emissions: an objective technique for the screening of hearing loss in children treated with platin derivatives. Int J Audiol. 2006 Jun;45(6):337-43. doi: 10.1080/14992020600582117.

    PubMed 16777780

  • Gardner CD, Zehnder JL, Rigby AJ, Nicholus JR, Farquhar JW. Effect of Ginkgo biloba (EGb 761) and aspirin on platelet aggregation and platelet function analysis among older adults at risk of cardiovascular disease: a randomized clinical trial. Blood Coagul Fibrinolysis. 2007 Dec;18(8):787-93. doi: 10.1097/MBC.0b013e3282f102b1.

    PubMed 17982321

  • Gorga MP, Neely ST, Ohlrich B, Hoover B, Redner J, Peters J. From laboratory to clinic: a large scale study of distortion product otoacoustic emissions in ears with normal hearing and ears with hearing loss. Ear Hear. 1997 Dec;18(6):440-55. doi: 10.1097/00003446-199712000-00003.

    PubMed 9416447

  • Gorga MP, Stover L, Neely ST, Montoya D. The use of cumulative distributions to determine critical values and levels of confidence for clinical distortion product otoacoustic emission measurements. J Acoust Soc Am. 1996 Aug;100(2 Pt 1):968-77. doi: 10.1121/1.416208.

    PubMed 8759950

  • Hatzopoulos S, Di Stefano M, Campbell KC, Falgione D, Ricci D, Rosignoli M, Finesso M, Albertin A, Previati M, Capitani S, Martini A. Cisplatin ototoxicity in the Sprague Dawley rat evaluated by distortion product otoacoustic emissions. Audiology. 2001 Sep-Oct;40(5):253-64.

    PubMed 11688544

  • Hibatallah J, Carduner C, Poelman MC. In-vivo and in-vitro assessment of the free-radical-scavenger activity of Ginkgo flavone glycosides at high concentration. J Pharm Pharmacol. 1999 Dec;51(12):1435-40. doi: 10.1211/0022357991777083.

    PubMed 10678500

  • Huang T, Cheng AG, Stupak H, Liu W, Kim A, Staecker H, Lefebvre PP, Malgrange B, Kopke R, Moonen G, Van De Water TR. Oxidative stress-induced apoptosis of cochlear sensory cells: otoprotective strategies. Int J Dev Neurosci. 2000 Apr-Jun;18(2-3):259-70. doi: 10.1016/s0736-5748(99)00094-5.

    PubMed 10715580

  • Rybak LP, Husain K, Morris C, Whitworth C, Somani S. Effect of protective agents against cisplatin ototoxicity. Am J Otol. 2000 Jul;21(4):513-20.

    PubMed 10912697

  • Kaltenbach JA, Church MW, Blakley BW, McCaslin DL, Burgio DL. Comparison of five agents in protecting the cochlea against the ototoxic effects of cisplatin in the hamster. Otolaryngol Head Neck Surg. 1997 Nov;117(5):493-500. doi: 10.1016/S0194-59989770020-2.

    PubMed 9374173

  • Kobuchi H, Droy-Lefaix MT, Christen Y, Packer L. Ginkgo biloba extract (EGb 761): inhibitory effect on nitric oxide production in the macrophage cell line RAW 264.7. Biochem Pharmacol. 1997 Mar 21;53(6):897-903. doi: 10.1016/s0006-2952(96)00873-8.

    PubMed 9113109

  • Meyerhoff WL, Maale GE, Yellin W, Roland PS. Audiologic threshold monitoring of patients receiving ototoxic drugs. Preliminary report. Ann Otol Rhinol Laryngol. 1989 Dec;98(12 Pt 1):950-4. doi: 10.1177/000348948909801206.

    PubMed 2589763

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ginkgo Biloba Extract (GBE761) in people with Ototoxicity and Hearing Loss, run by University of Brasilia at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01139281, which also lists 56 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2010.

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