UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046784 |
|---|---|
| Receipt number | R000053358 |
| Scientific Title | Efficacy of comprehensive nutritional management in the treatment of head and neck cancer |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2025/02/02 15:18:31 |
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Basic information
Public title
Efficacy of comprehensive nutritional management in the treatment of head and neck cancer
Acronym
Efficacy of comprehensive nutritional management in the treatment of head and neck cancer
Scientific Title
Efficacy of comprehensive nutritional management in the treatment of head and neck cancer
Scientific Title:Acronym
Efficacy of comprehensive nutritional management in the treatment of head and neck cancer
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether our comprehensive nutritional management activities have a beneficial effect on the treatment of head and neck cancer in patients with head and neck cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of side effects of cancer treatment
Key secondary outcomes
Nutrition-related blood data (albumin, prealbumin, zinc)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients treated for head and neck cancer (reconstructive surgery, chemotherapy, radiation therapy, chemoradiation therapy) at our hospital
Key exclusion criteria
Patients who visited our hospital for a second opinion, etc., and are not treated at our hospital.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Suehiro |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, JAPAN
TEL
075-751-3346
a_suehiro@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Suehiro |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, JAPAN
TEL
075-751-3346
Homepage URL
a_suehiro@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
self-financing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before the start
Management information
Registered date
| 2022 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053358
