UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030506 |
|---|---|
| Receipt number | 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 13:33:30 |
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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
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
ftatsuya@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university graduate school of medicine, department of Otolaryngology-head and neck surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034352
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/07/01 | C180094_PRT_v9.1_20230205.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
