UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of intravenous L-carnitine in fatigue-improvement on the patients bearing endstage cancer
Title of the study (Brief title)	Exploratory study of intravenous L-carnitine in fatigue-improvement on the patients bearing endstage cancer
Region	Japan

Condition
Condition	Malignancy
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Confirmation of efficacy of intravenous L-carnitine in the fatigue-palliation on the patients bearing endstage cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cancer Fatigue Scale
Key secondary outcomes	Numeric rating scale of fatigue Objective evaluation by the medical staff

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	One thousand milligram per day of L-Cartin FF(TM) injection is given for seven consecutive days
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients bearing endstage cancer hospitalized at palliative care unit Appeal for fatigue Agreement of the attending research doctor
Key exclusion criteria	More than a symptom except fatigue are/is not relieved Three days have not passed from hospitalization in palliative care unit Change in the opioids doses within three days before entry Change in adrenocorticosteroid doses within three days before entry An intravenous feeding route is not secured
Target sample size	10

Research contact person
Name of lead principal investigator	Eiji Mukai
Organization	Mitoyo General Hospital
Division name	Department of pharmaceutical services
Address	708 Himehama, Toyohama, Kan-onji, Kagawa, JAPAN
TEL	0875-52-3366
Email	mukai@mitoyo-hosp.jp

Public contact
Name of contact person	Junko Nakanishi
Organization	Mitoyo General Hospital
Division name	Department of pharmaceutical services
Address	708 Himehama, Toyohama, Kan-onji, Kagawa, JAPAN
TEL	0875-52-3366
Homepage URL
Email	junko-ph@mitoyo-hosp.jp

Sponsor
Institute	Mitoyo General Hospital
Institute
Department

Funding Source
Organization	Mitoyo General Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 31 Day
Anticipated trial start date	2017 Year 04 Month 24 Day
Last follow-up date
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 20 Day
Last modified on	2018 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031030