UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026214 |
|---|---|
| Receipt number | 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 11:54:44 |
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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
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
tomiura@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030114
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
