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

NCT01139281 | Completed Phase 2 DMC

• 1 other identifier: CEPSESDF-024-07
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ototoxicity; Hearing Loss

Keywords

Ear protection; Ginkgo Biloba Extract; Distortion-product otoacoustic emission; Ototoxicity; Cisplatin

Outcome Measures

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.

  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

Study Arms (2)

Study Group

ACTIVE COMPARATOR

The Study Group(SG) received Ginkgo biloba extract(GBE761)(240mg/day)plus cisplatin(CDDP)

Drug: Ginkgo Biloba Extract (GBE761)

Control Group(CG)

PLACEBO COMPARATOR

The Control Group received Placebo plus CDDP

Drug: Placebo

Interventions

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.

Also known as: Study Group

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.

Also known as: Control Group

Control Group(CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Hospital de Base do Distrito Federal (HBDF)

Brasília, Federal District, 70000-000, Brazil

Location

Related Publications (56)

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  PMID: 10459293 RESULT

• Huang X, Whitworth CA, Rybak LP. Ginkgo biloba extract (EGb 761) protects against cisplatin-induced ototoxicity in rats. Otol Neurotol. 2007 Sep;28(6):828-33. doi: 10.1097/mao.0b013e3180430163.

  PMID: 17450108 RESULT

MeSH Terms

Conditions

Ototoxicity; Hearing Loss

Interventions

Ginkgo biloba extract; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mirela A Dias

  University of Brasilia

  PRINCIPAL INVESTIGATOR

• Carlos CP Oliveira

  University of Brasilia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 8, 2010
• Study Start: June 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 8, 2010

Record last verified: 2010-05

Locations

BR (1)