UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018712 |
|---|---|
| Receipt number | R000021651 |
| Scientific Title | Characteristics of muscular function in cancer patients receiving the conservative therapy |
| Date of disclosure of the study information | 2015/08/18 |
| Last modified on | 2021/02/20 12:20:17 |
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Basic information
Public title
Characteristics of muscular function in cancer patients receiving the conservative therapy
Acronym
Characteristics of muscular function in cancer patients receiving the conservative therapy
Scientific Title
Characteristics of muscular function in cancer patients receiving the conservative therapy
Scientific Title:Acronym
Characteristics of muscular function in cancer patients receiving the conservative therapy
Region
| Japan |
Condition
Condition
1)Cancer patients receiving the conservative therapy
2)Community-dwelling elderly subjects
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1)To clarify the characteristic of physical function in cancer patients by comparing with community-dwelling elderly subjects
2)To clarify the effects of rehabilitation in cancer patients by measuring the longitudinal change of physical function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
skeletal muscle mass
Key secondary outcomes
grip strength
knee extent strength
physical activity
10-m walking test
Timed up and go test
Activity of Daily Living
fatigue
anxiety and depression
self-efficacy
Quality of Life
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)Cancer patients receiving conservative therapy in the hospital,community-dwelling healthy subjects
2)Subjects who are possible to perform exercise and evaluation
3)Subjects who obtained consent by his/her own will
Key exclusion criteria
1)Subjects considered inappropriate by the doctor in charge or study investigator
2)Subjects with poor general status
3)Subjects with severe heart or respiratory disease,hepatic or renal failure
4)Subjects with cerebrovascular or orthopedic disease that have a great influence on the physical function
5)Subjects who are impossible to communicate and understand the purpose of study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Fukushima |
Organization
Nagasaki University, Graduate School of Biomedical Science
Division name
Rehabilitation Science
Zip code
Address
1-7-1, Sakamoto, Nagasaki-shi, Nagasaki, 852-8520, Japan
TEL
095-819-7919
takuyafukushima321@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Fukushima |
Organization
Nagasaki University, Graduate School of Biomedical Science
Division name
Rehabilitation Science
Zip code
Address
1-7-1, Sakamoto, Nagasaki-shi, Nagasaki, 852-8520, Japan
TEL
095-819-7919
Homepage URL
takuyafukushima321@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University, Graduate School of Biomedical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research, Scientific Research
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
Address
Tel
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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 18 | 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
| 2015 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
skeletal muscle mass
grip strength
knee extent strength
physical activity
10-m walking test
Timed up and go test
Activity of Daily Living
fatigue
anxiety and depression
self-efficacy
Quality of Life
Management information
Registered date
| 2015 | Year | 08 | Month | 18 | Day |
Last modified on
| 2021 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021651
