UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057413 |
|---|---|
| Receipt number | R000065593 |
| Scientific Title | Study of Factors Related to Physical Function in Hematologic Cancer Patients |
| Date of disclosure of the study information | 2025/03/26 |
| Last modified on | 2025/03/26 16:42:13 |
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Basic information
Public title
Locomotive Syndrome in Hematologic Cancer Patients
Acronym
HECALOS
Scientific Title
Study of Factors Related to Physical Function in Hematologic Cancer Patients
Scientific Title:Acronym
HECALOST
Region
| Japan |
Condition
Condition
Hematologic Cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Geriatrics |
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of factors associated with locomotive syndrome in hematologic cancer patients hospitalized for chemotherapy.
Basic objectives2
Others
Basic objectives -Others
Examination of factors associated with physical function and activities of daily living in hematologic cancer patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Performance Status, Locomotive Syndrome (25-question Geriatric Locomotive Function Scale), Sarcopenia, Activities of Daily Living Independence Level
Key secondary outcomes
Physical function (grip strength, walking speed, chair rise time (SPPB), balance function, calf circumference)
Nutritional indicators (GNRI, PNI, CONUT, modified CONUT)
Inflammatory markers (CRP)
Comorbidities
Coexisting diseases
Prognosis
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized for chemotherapy for hematologic cancer who underwent rehabilitation.
Key exclusion criteria
25-question Geriatric Locomotive Function Scale not performed
Hematologic diseases such as aplastic anemia, autoimmune thrombocytopenia, and myelodysplastic syndromes, which undergo chemotherapy similar to that for hematologic cancers
Patients with consciousness disturbance (JCS I-1 or higher) at the time of admission
Patients with dementia requiring care in daily life (activities of daily living independence level III or higher for elderly individuals with dementia)
Patients with a history of central nervous system disorders with clear clinical symptoms such as paralysis or sensory disturbances
Patients with a history of peripheral nerve disorders with clear clinical symptoms such as paralysis or sensory disturbances
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuse |
Organization
Kurume University
Division name
Rehabilitation center
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942353311
matsuse_hiroh@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuse |
Organization
Kurume University
Division name
Rehabilitation center
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942353311
Homepage URL
matsuse_hiroh@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Self-Funding
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
Ethics Committee of Kurume University
Address
67 Asahi-machi, Kurume, Fukuoka
Tel
0942-31-7200
kcrc_jimu@kurume-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
久留米大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 26 | 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
367
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
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 04 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 11 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 14 | Day |
Other
Other related information
Retrospective observational study
Study period: April 1, 2019, to March 31, 2024
Management information
Registered date
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065593
