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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026214
Receipt No. R000030114
Scientific Title The study to explore the factors correlated with fatigue and anorexia in patients with advanced cancer at palliative care unit
Date of disclosure of the study information 2017/02/20
Last modified on 2020/02/22

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Basic information
Public title The study to explore the factors correlated with fatigue and anorexia in patients with advanced cancer at palliative care unit
Acronym The exploration for the factors correlated with cancer-related fatigue or anorexia
Scientific Title The study to explore the factors correlated with fatigue and anorexia in patients with advanced cancer at palliative care unit
Scientific Title:Acronym The exploration for the factors correlated with cancer-related fatigue or anorexia
Region
Japan

Condition
Condition Solid tumor
(Exclude: breast cacner, prostate cancer, renal cell carcinoma, hematologic tumor)
Classification by specialty
Medicine in general Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the factors correlated with fatigue and anorexia in patients with advanced cancer at palliative care uni
Basic objectives2 Others
Basic objectives -Others the correlation between fatigue/anorexia and other factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes carnitine
Key secondary outcomes inventory of fatigue/anorexia, cytokines, mRNA of PBMC, fecus

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 Patients who are
1) advanced cancer diagnosed by clinical or pathological investigation
2) in palliative care unit at national cancer center hospital east
3) more than 20 years old
4) able to understand Japanese
Key exclusion criteria Patients who are
1) breast cancer, prostate cancer, renal cell carcinoma and hematologic tumors
2) in a disturbance of consciousness (positive for confusion assessment method)
3) administered with corticosteroid within a week.
4) severe physical symptoms or distress
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomofumi Miura
Organization National Cancer Center Hospital East
Division name Division of Palliative Medicine
Zip code
Address Kashiwanoha 6-5-1, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email tomiura@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomofumi Miura
Organization National Cancer Center Hospital East
Division name Division of Palliative Medicine
Zip code
Address Kashiwanoha 6-5-1, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email tomiura@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization National Cancer Center Hospital
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 02 Month 20 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
2016 Year 12 Month 12 Day
Date of IRB
2016 Year 12 Month 12 Day
Anticipated trial start date
2016 Year 12 Month 20 Day
Last follow-up date
2019 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study has been completed

Management information
Registered date
2017 Year 02 Month 19 Day
Last modified on
2020 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030114

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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