UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053236 |
|---|---|
| Receipt number | R000060753 |
| Scientific Title | Prospective study to test the effectiveness of surgery for improving function of swallowing in head and neck cancer patients using high-resolution manometry |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2023/12/27 10:50:22 |
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Basic information
Public title
Prospective study to test the effectiveness of surgery for improving function of swallowing in head and neck cancer patients using high-resolution manometry
Acronym
Prospective study to test the effectiveness of surgery for improving function of swallowing in head and neck cancer patients using high-resolution manometry
Scientific Title
Prospective study to test the effectiveness of surgery for improving function of swallowing in head and neck cancer patients using high-resolution manometry
Scientific Title:Acronym
Prospective study to test the effectiveness of surgery for improving function of swallowing in head and neck cancer patients using high-resolution manometry
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate swallowing pressure using high-resolution manometry and to test the effectiveness of surgery for improving function of swallowing performed in conjunction with head and neck cancer reconstructive surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in swallowing pressure before surgery and 1 month after surgery for improving function of swallowing
Key secondary outcomes
Changes in swallowing pressure before surgery and 1 month after surgery in cases without surgery for improving function of swallowing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
In this study, we use high-resolution manometry to examine patients with head and neck cancer who underwent reconstructive surgery after resection of one or both suprahyoid muscles. Measurements are taken of swallowing through the cervical oesophagus.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a histopathological diagnosis of malignant tumour of the head and neck who undergo surgical resection of part or all of the suprahyoid muscle group.
Key exclusion criteria
Patients undergoing laryngectomy or who have already undergone laryngectomy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Sasaki |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Head and Neck
Zip code
135-8550
Address
3-8-31 Ariake Koto-ku Tokyo 135-8550 Japan
TEL
03-3520-0111
tsasaki@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Morita |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Head and Neck
Zip code
135-8550
Address
3-8-31 Ariake Koto-ku Tokyo 135-8550 Japan
TEL
03-3520-0111
Homepage URL
takuma.morita@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Foundation for Cancer Research
Address
3-8-31 Ariake Koto-ku Tokyo 135-8550 Japan
Tel
03-3520-0111
med.shinsa@jfcr.or.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
| 2024 | Year | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060753
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
