UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054708 |
|---|---|
| Receipt number | R000062523 |
| Scientific Title | Cross-sectional study on the prevalence of sarcopenia and its association with physical function in patients with unresectable stage IV lung cancer undergoing drug therapy |
| Date of disclosure of the study information | 2024/06/19 |
| Last modified on | 2025/06/20 09:15:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Cross-sectional study on the prevalence of sarcopenia and its association with physical function in patients with unresectable stage IV lung cancer undergoing drug therapy
Acronym
Cross-sectional study on the prevalence of sarcopenia and its association with physical function in patients with unresectable stage IV lung cancer undergoing drug therapy
Scientific Title
Cross-sectional study on the prevalence of sarcopenia and its association with physical function in patients with unresectable stage IV lung cancer undergoing drug therapy
Scientific Title:Acronym
Cross-sectional study on the prevalence of sarcopenia and its association with physical function in patients with unresectable stage IV lung cancer undergoing drug therapy
Region
| Japan |
Condition
Condition
Lung cancer(stage4)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to exploratoryly investigate the prevalence of sarcopenia, presarcopenia, and dynapenia in patients with unresectable stage IV lung cancer undergoing drug therapy, and the relationship between each condition and physical function.
Basic objectives2
Others
Basic objectives -Others
Prevalence survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of sarcopenia
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) Persons who have received a request for rehabilitation from the clinical department while hospitalized.
2) Persons who have given consent to undergo rehabilitation.
3) Persons who do not have significant joint range of motion limitations, sensory disorders, or motor paralysis in their limbs
4) Persons who can walk independently (with or without walking aids)
Key exclusion criteria
1) Persons whose consent for this research was not obtained
2) Persons with a history of other malignant tumors
3) Persons with a pacemaker implanted
4) Persons who have restrictions on the degree of rest during rehabilitation during hospitalization
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tsubaki |
Organization
University of Tsukuba Hospital
Division name
rehabilitation department
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
0298533795
tsubaki.takumi.kw@ms.hosp.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tsubaki |
Organization
University of Tsukuba Hospital
Division name
rehabilitation department
Zip code
3058576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
0298533795
Homepage URL
tsubaki.takumi.kw@ms.hosp.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
0298533795
tsubaki.takumi.kw@ms.hosp.tsukuba.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
| 2024 | Year | 06 | Month | 19 | 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
24
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062523
