UMIN-CTR Clinical Trial

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

None (healthy male volunteers)

Classification by specialty

Oto-rhino-laryngology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

AstaReal Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学病院（京都府）

Date of disclosure of the study information

2015

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

No problems.

Registered date

2015

Year

06

Month

03

Day

Last modified on

2016

Year

03

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020607