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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030506
Receipt No. R000034352
Scientific Title A reserch of swallowing pressure mesured by high resolution manometory after chemoradiotherapy for patients with head and neck cancer
Date of disclosure of the study information 2018/03/31
Last modified on 2020/06/28

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Basic information
Public title A reserch of swallowing pressure mesured by high resolution manometory after chemoradiotherapy for patients with head and neck cancer
Acronym A reserch of swallowing pressure mesured by high resolution manometory after chemoradiotherapy for patients with head and neck cancer
Scientific Title A reserch of swallowing pressure mesured by high resolution manometory after chemoradiotherapy for patients with head and neck cancer
Scientific Title:Acronym A reserch of swallowing pressure mesured by high resolution manometory after chemoradiotherapy for patients with head and neck cancer
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To detect of changing swallowing pressure after chemoradiotherapy for patients with head and neck cancer
Basic objectives2 Others
Basic objectives -Others To evaluate the correlation with swallowing pressure and common test of swallowing function
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Evaluation for swallowing pressure at 3 and 12 months after chemoradiotherapy. Calcurate the rate of changing in these two times.
Key secondary outcomes To evaluate the correlation with swallowing pressure and common test of swallowing function

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 twaice high resolution manometory
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

Not applicable
Gender Male and Female
Key inclusion criteria Over 20 year-old
no recurrent of head and neck cancer
patients with consent by paper
Key exclusion criteria patients with dysphagia before having a head and neck cancer
having past history of other head and neck cancer and advanced esophageal cancer
allergic for local anesthesis
pregnancy
having a severe cardiovascular disease
uncontrolled hepatitis B virus
evaluated for exclude by reserch docter
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Ken-ichi
Middle name
Last name nibu
Organization Kobe university graduate school of medicine
Division name department of Otolaryngology-head and neck surgery
Zip code 6500017
Address Hyogo, kobe, tyuuouku, kusunokityou,7-5-2
TEL 078-382-6024
Email nibu@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Furukawa
Organization Kobe university graduate school of medicine
Division name department of Otolaryngology-head and neck surgery
Zip code 6500017
Address Hyogo, kobe, tyuuouku, kusunokityou,7-5-2
TEL 078-382-6024
Homepage URL
Email ftatsuya@med.kobe-u.ac.jp

Sponsor
Institute Kobe university graduate school of medicine, department of Otolaryngology-head and neck surgery
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kobe University Clinical Research Ethical Committee
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe , Japan
Tel 078-382-6669
Email cerb@med.kobe-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 神戸大学病院(兵庫県)、東京大学(東京都)、名古屋大学(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 31 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 22 Day
Date of IRB
2018 Year 03 Month 29 Day
Anticipated trial start date
2018 Year 04 Month 01 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
2017 Year 12 Month 21 Day
Last modified on
2020 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034352

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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