UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035351 |
|---|---|
| Receipt number | R000039068 |
| Scientific Title | On the relationship between the amount of physical activity during preoperative chemotherapy and the Muscle Loss Index in patients with esophageal cancer - Pilot study for multi - occupational collaborative intervention - |
| Date of disclosure of the study information | 2020/01/04 |
| Last modified on | 2022/06/26 12:21:57 |
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Basic information
Public title
On the relationship between the amount of physical activity during preoperative chemotherapy and the Muscle Loss Index in patients with esophageal cancer - Pilot study for multi - occupational collaborative intervention -
Acronym
Study of esophageal cancer patients
Scientific Title
On the relationship between the amount of physical activity during preoperative chemotherapy and the Muscle Loss Index in patients with esophageal cancer - Pilot study for multi - occupational collaborative intervention -
Scientific Title:Acronym
Study of esophageal cancer patients
Region
| Japan |
Condition
Condition
Esophagus cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verify the relationship between physical activity level and skeletal muscle atrophy of esophageal cancer patients during chemotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle mass
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
1.aged at the time of obtaining 65 years or older 2.gender: male 3.stage: stage2-4 (esophageal cancer handling regulation 11th edition) 4.plan to implement DCF 2 courses as NAC 5.agree to participate in research by free will Can be obtained from the person himself / herself 6.I understand the clinical significance of this research and its importance
Key exclusion criteria
1.not having sarcopenia at recruitment based on criteria advocated by EWGSOP (European Working Group on Sarcopeneia in Older People) and Cut-off value of JSH (Japan Society of Hepatology) SARCOPENIA and diagnosis 3 1.SMI: 7.0 ( Less than 2 kg) 3. Grip strength: less than 26 (kg) 3. Walking speed: 0.8 (m / sec) or less 2) Effect on outcome such as cognitive dysfunction, cerebrovascular disorder, orthopedic disease, peripheral vascular disorder 3.It has electronic devices such as pacemakers whose measurement of Inbody is contraindicated 4.Has a gastrostomy due to eating difficulties
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ikeda |
Organization
OKAYAMA UNIVERSITY HOSPITAL
Division name
General rehabilitation department
Zip code
7008558
Address
700-8558,Okayamashi,kitaku,ksikatacho,2-5-1
TEL
0862357752
lirfranjitte@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ikeda |
Organization
OKAYAMA UNIVERSITY HOSPITAL
Division name
General rehabilitation department
Zip code
7008558
Address
700-8558,Okayamashi,kitaku,sikatacho,2-5-1
TEL
086-235-7752
Homepage URL
lirfranjitte@yahoo.co.jp
Sponsor or person
Institute
OKAYAMA UNIVERSITY HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
nothing
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
OKAYAMA UNIVERSITY HOSPITAL
Address
Okayamashi,kitaku,sikatacho,2-5-1
Tel
0862357752
lirfranjitte@yahoo.co.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
| 2020 | Year | 01 | Month | 04 | 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
10
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the spread of COVID-19 infection
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
| 2018 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 10 | Day |
Other
Other related information
nothing
Management information
Registered date
| 2018 | Year | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039068
