UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057869 |
|---|---|
| Receipt number | R000066147 |
| Scientific Title | Changes in sarcopenia and dynapenia indexes and their relationship to nutrition and social life. |
| Date of disclosure of the study information | 2025/05/14 |
| Last modified on | 2026/06/17 10:19:43 |
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Basic information
Public title
Sarcopenia and dynapenia in patients with head and neck cancer:
Changes in sarcopenia and dynapenia indexes and their relationship to nutrition and social life.
Acronym
Sarcopenia and dynapenia in patients with head and neck cancer
Scientific Title
Changes in sarcopenia and dynapenia indexes and their relationship to nutrition and social life.
Scientific Title:Acronym
Sarcopenia and dynapenia in patients with head and neck cancer
Region
| Japan |
Condition
Condition
Oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer
Classification by specialty
| Oto-rhino-laryngology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to elucidate the transition patterns of sarcopenia and dynapenia indices from the period of chemoradiotherapy and radiotherapy to 12 months after treatment in patients with head and neck cancer (oral cavity, mid-pharynx, hypopharynx, and larynx cancer) and to explore the relationship with nutrition management and social life factors.
Basic objectives2
Others
Basic objectives -Others
1) The number of cases of non-sarcopenia, pre-sarcopenia, dynapenia, and sarcopenia (before treatment, after treatment,)
2) Patients' difference (no sarcopenia, pre-sarcopenia, dynapenia, and sarcopenia) could respond to treatment,
3) Changes in sarcopenia and dynapenia indices during treatment. These changes are related to patient attributes, treatment course, symptoms, nutrition during treatment, rehabilitation, changes in activity level, and quality of life.
4) Changes in sarcopenia-dynapenia indices after treatment ends and relation with the patient's social background, social life, psychosocial factors, nutrition during treatment, rehabilitation, and changes in activity level.
5) The way the sarcopenia-dynapenia index changes during treatment is related to the way it changes after treatment ends.
(6) Finding out what causes the change (transition) in the sarcopenia-dynapenia index.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patterns of change in sarcopenia and dynapenia indices from CRT/RT period to 12 months after completion of treatment (transition)
Key secondary outcomes
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Age 20 years or older at the time of obtaining consent.
(2) Patients whose disease originates in the oral cavity, mid-pharynx, hypopharynx, or larynx
(3) Patients who are diagnosed with head and neck cancer and will receive chemoradiotherapy or radiotherapy as an inpatient at this hospital.
(4) Patients who have already completed the inpatient treatment described in (iii) above and are currently or will be undergoing outpatient treatment.
(5) Subjects who have been fully informed about their participation in this study, and who have given their free and voluntary written consent based on their full understanding of the study.
Key exclusion criteria
(1) Patients for treatment of recurrence or metastasis
(2) Patients with a diagnosis of cognitive dysfunction or psychiatric disease
(3) Patients with implantable medical devices (cardiac pacemakers, etc.) or medical devices necessary for life support (bioinformatics monitors)
(4) Patients who will experience physical and mental stress due to participation in the research
(5) Other patients whom the principal investigator judges to be inappropriate as research subjects.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University Faculty of Health Sciences
Division name
Nursing division
Zip code
0600812
Address
Kita12 Nishi 5, Kita-ku,Sapporo city
TEL
011-716-1161
drnoji@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Sumi |
Organization
Hokkaido University Faculty of Health Sciences
Division name
Nursing division
Zip code
060-0812
Address
Kita 12 Nishi 5, Kita-ku, Sapporo city
TEL
011-716-1161
Homepage URL
nsumi@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japanese society of promotion for science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14 Nishi5, Kita-ku, Sapporo city
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2025 | Year | 05 | Month | 14 | 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
| 2025 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Basic information on research subjects
Treatment-related information
General condition: vital signs
Hematological examination
Blood biochemical tests
CT images
Nutritional management status
Swallowing function assessment
Sarcopenia and dysmenorrhea assessment
Activity assessment
International Physical Activity Questionnaire (IPAQ) Japanese version Nutritional assessment
Quality of Life
Symptoms: EORTC QLQ-H&N35
Life and social status: economic status, diet-related matters, dietary difficulties
Expected period of participation in research by research subjects
Each research subject will participate in the following two time periods, depending on the timing of treatment after consent.
Study period 1 (for those: Participation will commence from the start of CRT/RT to 12 months after treatment completion,
Survey period 2 (for those who have) Participants will be followed for 12 months after the end of CRT/RT. Medical information will be surveyed during the same period
Management information
Registered date
| 2025 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066147
