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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017788
Receipt No. R000020607
Scientific Title Protection of the vocal fold by modulation of oxidative stress
Date of disclosure of the study information 2015/07/01
Last modified on 2016/03/16

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Basic information
Public title Protection of the vocal fold by modulation of oxidative stress
Acronym Protection of the vocal fold
Scientific Title Protection of the vocal fold by modulation of oxidative stress
Scientific Title:Acronym Protection of the vocal fold
Region
Japan

Condition
Condition None (healthy male volunteers)
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effect of vocal fold protection with astaxanthin after vocal loading as a prospective study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Affected degree of each vocal assessment, vocal fatigue index and stroboscopic examination between 1st and 2nd vocal loading.
Stroboscopic examination, aerodynamic assessment, acoustic analysis, GRBAS scale, and vocal fatigue index are performed after vocal loading.
Aerodynamic assessment includes maximum phonation time(MPT),mean flow rate(MFR) and AC/DC ratio: vocal efficiency index. Acoustic analysis evaluates pitch perturbation quotient(PPQ),amplitude perturbation quotient(APQ),noise to harmonic ratio(NHR).
Key secondary outcomes None

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The first assessment is the day 0.
The subjects were applied first assessment of stroboscopic examination, aerodynamic assessment, acoustic analysis, GRBAS scale, and vocal fatigue index at ENT department of Kyoto university hospital.
After the first assessment, they undergo first vocal loading for 60 minutes with 80dB voice, taking rest s every 15 minutes. Vocal assessments are performed just after and 30 minutes after vocal loading.
Interventions/Control_2 After the first vocal loading, they receive Astaxanthin and have explanations as below.
To take Astaxanthin from one week later (Day 7).
To take Astaxanthin 24mg/day, twice a day for 28 days (from Day7- to day34).
Refrain from excessive talking from Day0 to Day35.
To come to visit ENT department of Kyoto university hospital and perform second vocal loading.
Just after and 30 minutes after second vocal loading, vocal assessments are performed.
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

Not applicable
Gender Male
Key inclusion criteria Healthy volunteers who agree to join this study.
Over 20 years men for agreement.
No organic or functional diseases of larynx.
Key exclusion criteria The subjects with a history of radiation therapy for the larynx.
The subjects who underwent phonomicrosurgery during this 6 months.
Smokers
The subjects who cannot follow the doctors instruction.
The subjects with a heart or lung disease, who easily become tired upon phonation.
The subjects who are judged as inappropriate candidates by the doctor.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Hirano
Organization Graduate School of Medicine
Kyoto University
Division name Department of Otolaryngology Head and Neck Surgery
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku Kyoto 606-8507
TEL 075-751-3346
Email hirano@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mami Kaneko
Organization Graduate School of Medicine
Division name Department of Otolaryngology Head and Neck Surgery
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku Kyoto 606-8507
TEL 075-751-3346
Homepage URL
Email m_kaneko@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Otolaryngology Head and Neck Surgery
Graduate School of Medicine
Kyoto University
Institute
Department

Funding Source
Organization AstaReal Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 京都大学病院(京都府)

Other administrative information
Date of disclosure of the study information
2015 Year 07 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
Whole enrolled case: 10
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
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2016 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No problems.

Management information
Registered date
2015 Year 06 Month 03 Day
Last modified on
2016 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020607

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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