Determination and comparison of cisplatin otoprotection using intratympanic diltiazem and placebo among patients with solid cancer
Design
In this study, 25 patients (Cases:25 ears and Controls:25 ears) with solid cancer who were referred to Amiralmomenin Hospital in Rasht are selected. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
In this study, 25 patients (Cases:25 ears and Controls:25 ears) with solid cancer who were referred to Amiralmomenin Hospital are evaluated by double-blind randomized clinical trial method. We obtain informed consent from all participants. A comprehensive history taking, including history of ear diseases is taken. Then a physical examination of the ear is performed using a microscope , before each course of course of chemotherapy. Diltiazem Drug is injected middle ear. Then participation is asked to supine on Opposite ear, Avoid Swallow, and Cough for 20 minute. A hearing test is also conducted one week and one month after the last chemotherapy course
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years old; Presence of Acoustic Reflex or Tympanometry A; Average hearing threshold less than 40 dB; The hearing threshold on either side should not be asymetric or there is less than 10 dB; The karnofsky index is equal to or greater than 70
Exclusion criteria: History of previous internal ear; History of Meniere's disease Or Fluctuating hearing loss; Observing Pathologic findings in otoscopy; Previously cisplatin has not been treated; Radiation History to the head and neck Area; Candidate for radiation to the head and neck; Liver and Renal failure; Conductive hearing loss more than 5 dB; Heart problems
Intervention groups
The ear receiving diltiazem solution
The ear receiving the placebo
Main outcome variables
Hearing Loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081202001483N4
Registration date:2018-09-16, 1397/06/25
Registration timing:prospective
Last update:2018-09-16, 1397/06/25
Update count:0
Registration date
2018-09-16, 1397/06/25
Registrant information
Name
Mir Mohammad Jalali
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1324 3085
Email address
mmjalali@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cisplatin otoprotection using intratympanic diltiazem and placebo among patients with solid cancer
Public title
Evaluation of effect injection of diltiazem into middle ear on the hearing loss due to Cisplatin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Presence of Acoustic Reflex or Tympanometry A
In PTA, average hearing threshold at frequencies of 3000-5000 or 8000 to 4000 less than 40 dB
In PTA, the hearing threshold on either side should not be asymetric within 3000 to 5000 or 8000-4000 Hz frequencies or there is less than 10 dB
The karnofsky index is equal to or greater than 70
Exclusion criteria:
History of previous internal ear disease that may reduce the sensory nervous system hearing
History of Meniere's disease Or fluticating hearing loss
Observing pathologic findings in otoscopy
Previously cisplatin has not been treated
Radiation History to the head and neck Area
Candidate for radiation to the head and neck
Liver and Renal failure
Conductive hearing loss more than 5 dB
Heart problems, such as hypotension or AV block
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
Control ear and Case ear
Randomization (investigator's opinion)
Randomized
Randomization description
With using of Pass software , randomly assigned control Ear and intervention Ear
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to maintain double blindness in the study, both patients and all researchers will be unaware of the received drug. A researcher will explain about the drug to the patients and assign each ear to control ear or intervention ear according to the Random Number Table (PASS software). Same researcher will inject drug or placebo in middle ear under local anesthesia. Another researcher will evaluate the patients before and after intervention. Audiologist and patients will be blinded about type of intervention of each ear.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice-chancellor for Research Building, opposite of Sepah Bank,Shahid Beheshti Blvd
City
Rasht
Province
Guilan
Postal code
4139637459
Approval date
2018-08-18, 1397/05/27
Ethics committee reference number
IR.GUMS.REC.1397.186
Health conditions studied
1
Description of health condition studied
Hearing Loss
ICD-10 code
H91.0
ICD-10 code description
Ototoxic hearing loss
Primary outcomes
1
Description
Hearing Loss
Timepoint
One week and one month after the last dose of cisplatin
Method of measurement
Audiometry Test
2
Description
Low-frequency Average hearing threshold
Timepoint
One week and one month after the last dose of cisplatin
Method of measurement
Audiometry Test
3
Description
High-frequency Average hearing threshold
Timepoint
One week and one month after the last dose of cisplatin
Method of measurement
Audiometry Test
Secondary outcomes
1
Description
Ototoxicity Grade
Timepoint
One week and one month after the last dose of cisplatin
Method of measurement
Audiometry( Grade changes)
2
Description
Complications of cisplatin injection
Timepoint
One week and one month after the last dose of cisplatin
Method of measurement
Questions From Patient
Intervention groups
1
Description
Intervention group: At first, Case-ear is filled with Xyla-P ointment. After 5 minute local anesthesia , ointment was suctioned under microscope. 0.7-1 cc of Diltiazem solution (5mg/ml) is injected through inferior-posterior quadrant of tympanic membrane into middle ear( near round niches). Then participation is asked to supine on opposite ear, avoid swallow, and cough for 20 minute
Category
Treatment - Drugs
2
Description
Control group: At first, control-ear is filled with Xyla-P ointment. After 5 minute local anesthesia , ointment was suctioned under microscope