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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029272
Receipt No. R000033460
Scientific Title Effect of exercise on sarcopenia in patients with pancreatic cancer
Date of disclosure of the study information 2017/10/05
Last modified on 2017/09/25

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Basic information
Public title Effect of exercise on sarcopenia in patients with pancreatic cancer
Acronym Pancreatic cancer and exercise
Scientific Title Effect of exercise on sarcopenia in patients with pancreatic cancer
Scientific Title:Acronym Pancreatic cancer and exercise
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Scarce data are currently available for the effect of exercise on quality of life for pancreatic cancer patients receiving physical exercise. The aims of the current study are to prospectively examine the effect of exercise on quality of life using actigram in patients with pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation for quality of life using actigram
Key secondary outcomes Questionaire survey
Clinical time course in baseline characteristics

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 Physical exercise
In the physical exercise group, we will conduct guidance to study participants at the outpatient nutrition guidance room. We will also instruct them to do exercise with more than 3 metabolic equivalents (Mets) for 60 minutes per day and to do exercise more than 23 Mets per week.
Standard therapy
Interventions/Control_2 Standard therapy
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 Pancreatic cancer patients receiving standard therapy
Key exclusion criteria 1.Patients with severe depression or psychiatric disorder
2.Patients with severe underlying diseases.
3.Pregnant or lactating female patients
4.Patients who were judged to be inappropriate for the study subjects
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuhei Nishiguchi
Organization Hyogo college of medicine
Division name Department of hepatobiliary and pancreatic disease, division of internal medicine
Zip code
Address 1-1, Mukogawacho, Nishinomiyashi, Hyogo, Japan
TEL 0798-45-6111
Email kantan@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Yoh
Organization Hyogo college of medicine
Division name Department of hepatobiliary and pancreatic disease, division of internal medicine
Zip code
Address 1-1, Mukogawacho, Nishinomiyashi, Hyogo, Japan
TEL 0798-45-6111
Homepage URL
Email mm2wintwin@yahoo.co.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization Hyogo college of medicine
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
Address
Tel
Email

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
2017 Year 10 Month 05 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
2017 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 25 Day
Last modified on
2017 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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