UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040491 |
|---|---|
| Receipt number | R000046063 |
| Scientific Title | Study on drug-induced inner ear disorders caused by anti-cancer agents |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2024/05/27 14:32:44 |
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Basic information
Public title
Study on drug-induced inner ear disorders caused by anti-cancer agents
Acronym
Study on drug-induced inner ear disorders
Scientific Title
Study on drug-induced inner ear disorders caused by anti-cancer agents
Scientific Title:Acronym
Study on drug-induced inner ear disorders
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess inner ear function in patients undergoing chemotherapy using audiometry and the Video Head Impulse Test.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hearing level and vHIT gain values 1,4,7,12,24 weeks after the first dose of anticancer drug
Key secondary outcomes
Creatinine clearance value 1,4,7,12,24 weeks after the first administration of anticancer drug
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform audiometry and video Head Impulse Test on patients undergoing chemotherapy.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients over the age of 20 who are diagnosed with head and neck cancer and plan to undergo chemotherapy
Key exclusion criteria
Patients with cervical spine disease, reduced neck mobility, pain and neurological symptoms
Patients who the investigator determined to be unsuitable for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Takahashi |
Organization
Kagawa University, Faculty of Medicine
Division name
Otolaryngology
Zip code
761-0793
Address
1750-1, Ikenobe, Mikichou, Kitagun, Kagawa,Japan
TEL
087-891-2214
takahashi.satoshi.1x@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Takahashi |
Organization
Kagawa University, Faculty of Medicine
Division name
Otolaryngology
Zip code
761-0793
Address
1750-1, Ikenobe, Mikichou, Kitagun, Kagawa,Japan
TEL
087-891-2214
Homepage URL
takahashi.satoshi.1x@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University School of Medicine Ethics Committee
Address
1750-1, Ikenobe, Mikichou, Kitagun, Kagawa,Japan
Tel
087-898-5111
kenkyushien@kagawa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046063
