UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030138 |
|---|---|
| Receipt number | R000034405 |
| Scientific Title | Evaluation of chemotherapy induced vestibulotoxicity |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/05/31 10:14:25 |
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Basic information
Public title
Evaluation of chemotherapy induced vestibulotoxicity
Acronym
Chemotherapy induced vestibulotoxicity
Scientific Title
Evaluation of chemotherapy induced vestibulotoxicity
Scientific Title:Acronym
Chemotherapy induced vestibulotoxicity
Region
| Japan |
Condition
Condition
vestibulopathy in patients treated with CDDP or CBDCA
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate vestibulotoxocity induced CDDP and CBDCA
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of VOR gain of vHIT and SVV depending on chemotherapy
Key secondary outcomes
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
vHIT and SVV
before administration of CDDP or CBDCA, each kur and one month after 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) hospitalization or visits from approval to 28 December 2020
2) capable of obtaining informed consent with free will
3) age: 20 and more than 20, less than 90
4) male and female
5) patients in hospital who will be treated with CDDP or CBDCA. Observation will be continued until one month after chemotherapy (also after discharge)
Key exclusion criteria
1) history of vertigo
2) history of lumbar vertebra disease
3) ear involvement of irradiation site
4) case in which first dose is less than normal dose due to original renal dysfunction
5) inappropriate case
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masakatsu |
| Middle name | |
| Last name | Taki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of of Otolaryngology - Head Neck Surgery
Zip code
602-8566
Address
465 Kajii-cho, Hirokoji Agaru, Kawaramachi-dori, Kamigyo, Kyoto
TEL
075-251-5603
taki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Masakatsu |
| Middle name | |
| Last name | Taki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of of Otolaryngology - Head Neck Surgery
Zip code
602-8566
Address
465 Kajii-cho, Hirokoji Agaru, Kawaramachi-dori, Kamigyo, Kyoto
TEL
075-251-5603
Homepage URL
taki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Hirokoji Agaru, Kawaramachi-dori, Kamigyo, Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2018 | Year | 02 | 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
7
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034405
