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 2022/05/26 13:34:25

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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

Email

takahashi.satoshi@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

takahashi.satoshi@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

Email

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

2023 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

2022 Year 05 Month 26 Day



Link to view the page

Value
https://center6.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