UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040491
Receipt No. 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 2020/05/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email sato4-t@med.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
Email sato4-t@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University
Institute
Department

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
Email chosa@med.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
2021 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
2020 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046063

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.