The aim of this study was to investigate the preventive effect of Sertraline on Cisplatin-induced ototoxicity. Randomized, single-blind, placebo-controlled, multicenter, Step three trial.
A total of 70 patients by blocked randomization divided into two groups. Inclusion criteria: patients with cancer who are scheduled to receive Cisplatin; aged 20 to 65 years.
Exclusion criteria: use of other ototoxic drugs or drugs that interfere with the use of Sertraline or Cisplatin, associated comorbidities, pregnancy or lactation, history of radiotherapy.
Coinciding with the start of Cisplatin Sertraline start with 25 mg once daily for the case group and if tolerated after three days increased to 50 mg per day and the drug continues during chemotherapy (3 months) . For the control group given a placebo for three months. Patients before beginning of Cisplatin and after completion of the drug and placebo Course placed under high frequency Tympano audiometery and Distortion Product Otoacoustic Emissions (dpOAE) and the results of the hearing loss (primary variable) and treatment complications (secondary variable) will be statistically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081927286N1
Registration date:2016-10-29, 1395/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-29, 1395/08/08
Registrant information
Name
Zahra Karbasi
Name of organization / entity
Iran Univerciy of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2122
Email address
karbasi.z@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial Comparison of Sertraline and Placebo to reduce Cisplatin-induced ototoxicity in patients with Cancer
Public title
Prevention of Cisplatin-induced ototoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with cancer who are scheduled to receive Cisplatin; aged 20 to 65 years.
Exclusion criteria: previous use of Cisplatin or any ototoxic drug; patients with Head and Neck cancer; age above 65 years; patients who use hearing aids or those associated with hearing loss in the past otalgic disease; Steroid user; patients with systemic diseases such as Diabetes, Hypertension, Thyroid disease, Kidney or Liver disease; pregnant or lactating women; patients with a history of Seizure; taking Monoamine Oxidase inhibitors; concomitant use of Antidepressants drugs; history of radiotherapy.
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Department of Research and Technology, 5th Floor, between the intersection of Sheikh Fazlollah and Martyr Chamran, West Martyr Hemmat Highway, Tehran
City
Tehran
Postal code
1449614535
Approval date
2016-09-04, 1395/06/14
Ethics committee reference number
IR.IUMS.REC 1395.9311369005
Health conditions studied
1
Description of health condition studied
Hearing loss
ICD-10 code
C85
ICD-10 code description
Other and unspecified types of non-Hodgkin lymphoma
2
Description of health condition studied
Hearing loss
ICD-10 code
C81
ICD-10 code description
Hodgkin lymphoma
3
Description of health condition studied
Hearing loss
ICD-10 code
C83
ICD-10 code description
Non-follicular lymphoma
4
Description of health condition studied
Hearing loss
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
Hearing frequencie
Timepoint
Before the intervention, After the intervention
Method of measurement
Distorsion product Otoacoustic Emission, High frequency tympanoaudiometery
Secondary outcomes
1
Description
The side effects of taking Sertraline
Timepoint
Before the intervention, After the intervention
Method of measurement
Interview
Intervention groups
1
Description
Case groups: Sertraline, 50 mg oral tablet, starting dose with 25 mg once daily and if tolerated 50 mg per day continues for 3 months
Category
Prevention
2
Description
Control group: placebo, Saccharin oral tablet, a daily pill for three months
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Prophet Muhammad (PBUH) Hospital
Full name of responsible person
Zahra Karbasi
Street address
Prophet Muhammad (PBUH) Research and Treatment Educational Centers, Street of Worship, Sattarkhan, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Zahra Karbasi
Street address
Firoozgar Hospital, Behafarin Street, Karim Khan Zand Street, Vali Asr Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Zahra Karbasi
Street address
Prophet Muhammad (PBUH) Research and Treatment Educational Centers, Street of Worship, Sattarkhan, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Medical System
Full name of responsible person
Zahra Karbasi
Position
Clinical Assistant
Other areas of specialty/work
Street address
Prophet Muhammad (PBUH) Research and Treatment Educational Centers, Street of Worship, Sattarkhan, Tehran
City
Tehran
Postal code
1313114456
Phone
+98 213169787
Fax
+98 982166525329
Email
Karbasi.z@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical System
Full name of responsible person
Mojtaba Maleki Delarestaghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Firoozgar Hospital, Behafarin Street, Karim Khan Zand Street, Vali Asr Street, Tehran
City
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Fax
+98 21 8894 2622
Email
Karbasi.z@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical System
Full name of responsible person
Zahra Karbasi
Position
Clinical Assistant
Other areas of specialty/work
Street address
Prophet Muhammad (PBUH) Research and Treatment Educational Centers, Street of Worship, Sattarkhan, Tehran
City
Tehran
Postal code
1313114456
Phone
+98 21 6435 2458
Fax
+98 21 6652 5329
Email
Karbasi.z@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)