48 cancer patients aged over 18 years who are candidates receiving cisplatin regimen with written consent will enter to the study. After taking hearing history and ear examination, audiometry and DPOAE tests; and filling the questionnaire tinnitus, if the above parametrs are within normal ranges patients,randomly, will distribute into two 24 persons groups.We will use the protocols of http://www.randomization.com for randomization (Block design). We will use Ginkgo T.D. tablets produced by Toliddaru Iran.Each tablet contains 40 mg Ginkgo Biloba leaf extract. The Placebo will be produced by Toliddaru and for blindness of the patients and examiners ,it will have the same packing,shape,taste,color and preservatives like the drug. At the beginning of a cisplatin regimen 240 mg of Ginkgo Biloba extract will give to patients daily in case group( 2 tablets TDS) and in the placebo group starch will give to patients daily (2 tablets TDS). Before starting each course of cisplatin regimen and six months after the completion of the above tests and questionnaires will be filled. At the end of the study, the results of DPOAE, audiometry and tinnitus severity of side effects between the two groups in any of the Impact Ginkgo Biloba extract will be reported.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020720982N1
Registration date:2015-11-02, 1394/08/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-02, 1394/08/11
Registrant information
Name
Mahtab Rabbani Anari
Name of organization / entity
Tehran Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2393
Email address
m_rabani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2018-04-01, 1397/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ginkgo Biloba extract in comparison with placebo on prevention of tinnitus and otoxicity in patients treated with cisplatin
Public title
Effect of Ginkgo Biloba extract in comparison with placebo on prevention of tinnitus and ototoxicity in patients treated with cisplatin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People over the age of 18 candidates for treatment with cisplatin regimen for first time
Exclusion criteria:
Middle ear disorders
Head and neck cancers
Gastrointestinal problems
Tendency to bleeding
Concomitant use of other ototoxic drugs
History of Ginkgo Biloba consumption
Inability to record DPOAE
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The committee of "Ethic in research" of TUMS
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-06-01, 1394/03/11
Ethics committee reference number
94-01-48-28864-151125
2
Ethics committee
Name of ethics committee
The committee of "Ethic in research" of TUMS
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-06-01, 1394/03/11
Ethics committee reference number
94-01-48-28864-151125
Health conditions studied
1
Description of health condition studied
Prevention of ototoxicity of cisplatin
ICD-10 code
H91.0
ICD-10 code description
Ototoxic hearing loss
Primary outcomes
1
Description
DPOAE
Timepoint
Before beginning of each chemotherapy course and 6 month after ending
Method of measurement
By Audiometry devise in decibel scale
2
Description
Tinnitus severity
Timepoint
Before beginning of each chemotherapy course and 6 month after ending
Method of measurement
From 0 to 100
3
Description
Ototoxicity severity
Timepoint
Before beginning of each chemotherapy course and 6 month after ending
Method of measurement
By Pure tone audiometry grading from 0 to 4
Secondary outcomes
1
Description
ِِِDrug side effects including Gastrointestinal and bleeding
Timepoint
Whole period of Ginkgo Biloba consumption
Method of measurement
Questionnaire
2
Description
Age
Timepoint
Before entering to study
Method of measurement
Questionnaire
3
Description
Sex
Timepoint
Before entering to study
Method of measurement
Questionnaire
4
Description
Anxiety
Timepoint
Before beginning of each chemotherapy course and 6 month after ending
Method of measurement
Anxiety questennaire
5
Description
Self esteem
Timepoint
Before beginning of each chemotherapy course and 6 month after ending
Method of measurement
Self esteem questionnaire
6
Description
Depression
Timepoint
Before beginning of each chemotherapy course and 6 month after ending
Method of measurement
Depression questionnare
7
Description
cis platin dose
Timepoint
Before beginning of each chemotherapy course
Method of measurement
In mg/ mm2
8
Description
Cancer type
Timepoint
Before entering to study
Method of measurement
Pathology report
9
Description
Medical history
Timepoint
Before entering to study
Method of measurement
Questionnaire
10
Description
Drug history
Timepoint
Before beginning of each chemotherapy course and 6 month after ending
Method of measurement
Questionnaire
11
Description
Renal and liver laboratory data
Timepoint
Before beginning of each chemotherapy course and 6 month after ending
Method of measurement
Laboratory ( Urea, Creatinin and liver enzymes)
Intervention groups
1
Description
Intervention group: Ginckgo Biloba prescription (2 tablets per 8 hours)
Category
Treatment - Drugs
2
Description
Control Group: Placebo prescription, 2 tablets per 8 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer institute
Full name of responsible person
Dr Sanambar Sedighi
Street address
Imam Khomeyni Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mahtab Rabbani Anari
Street address
Blv Keshavarz- Poor Sina Ave- Tehtran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Theran University of Medical Sceinces
Full name of responsible person
ِDr Mahtab Rabbani Anari
Position
Assisstant Professor
Other areas of specialty/work
Street address
Imam Khomeyni Hospital - Ear, nose and throat ward
City
Tehran
Postal code
Phone
+98 21 6119 2393
Fax
Email
m_rabani@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Theran University of Medical Sceinces
Full name of responsible person
ِDr Mahtab Rabbani Anari
Position
Assisstant Professor
Other areas of specialty/work
Street address
Imam Khomeyni Hospital - Ear, nose and throat ward
City
Tehran
Postal code
Phone
+98 21 6119 2393
Fax
Email
m_rabani@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Reza Erfanian
Position
Residence of ear, nose and throat
Other areas of specialty/work
Street address
Imam Khomeyni Hospital - Ear, nose and throat ward
City
Tehran
Postal code
Phone
+98 21 6693 1115
Fax
Email
rezakhosravimd@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)