UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057146 |
|---|---|
| Receipt number | R000065330 |
| Scientific Title | Effects of exercise and nutritional intervention programs on immune cells and inflammatory cytokines in blood cancer survivors with sarcopenia: a randomized controlled trial |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/02/27 12:26:57 |
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Basic information
Public title
Effects of exercise and nutritional intervention programs on immune cells and inflammatory cytokines in blood cancer survivors with sarcopenia: a randomized controlled trial
Acronym
Effects of exercise and nutritional intervention programs on immune cells and inflammatory cytokines in blood cancer survivors with sarcopenia: a randomized controlled trial
Scientific Title
Effects of exercise and nutritional intervention programs on immune cells and inflammatory cytokines in blood cancer survivors with sarcopenia: a randomized controlled trial
Scientific Title:Acronym
Effects of exercise and nutritional intervention programs on immune cells and inflammatory cytokines in blood cancer survivors with sarcopenia: a randomized controlled trial
Region
| Japan |
Condition
Condition
hematological malignancies
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of exercise and nutritional intervention programs on immune cells and inflammatory cytokines in blood cancer survivors with sarcopenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NK cell activity and two-color CD16/CD56 are measured as immune cell tests. TNF alpha and IL-6 are measured as inflammatory cytokine tests.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group will receive a 3-month exercise intervention and nutritional intervention. The exercise intervention will involve guidance on the target number of steps to walk per day and resistance training. The nutritional intervention will involve guidance on taking nutritional supplements twice a day, after exercise and at any time of day.
Interventions/Control_2
The control group received only usual care.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Age 18 or older at the time of obtaining consent
2 Survivors undergoing outpatient treatment after treatment for blood cancer
3 Patients who own a smartphone
4 Patients who have consented to participate in this study
5 Those who meet the criteria for sarcopenia according to the AWGS 2019 sarcopenia diagnostic criteria (Chen LM, et al. 2020)
Key exclusion criteria
1. Patients whose physical function assessment is affected by musculoskeletal disorders, cerebrovascular disorders, etc.
2. Patients whose physical function assessment is difficult due to complications
3. Patients who are unable to respond to questionnaires due to mental disorders or other complications
4. Patients whose attending physician deems participation in the study to be inappropriate
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Morishita |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
9601101
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
024-581-5538
morishit@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Morishita |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
9601101
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
024-581-5538
Homepage URL
morishit@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikariga-oka, Fukushima City 960-1295, JAPAN
Tel
024-547-1111
rs@fmu.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 | 02 | Month | 27 | 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
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065330
