UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000030114