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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027078
Receipt No. R000031030
Scientific Title Exploratory study of intravenous L-carnitine in fatigue-improvement on the patients bearing endstage cancer
Date of disclosure of the study information 2017/04/22
Last modified on 2018/04/26

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Basic information
Public title Exploratory study of intravenous L-carnitine in fatigue-improvement on the patients bearing endstage cancer
Acronym Exploratory study of intravenous L-carnitine in fatigue-improvement on the patients bearing endstage cancer
Scientific Title Exploratory study of intravenous L-carnitine in fatigue-improvement on the patients bearing endstage cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Eiji Mukai
Organization Mitoyo General Hospital
Division name Department of pharmaceutical services
Zip code
Address 708 Himehama, Toyohama, Kan-onji, Kagawa, JAPAN
TEL 0875-52-3366
Email mukai@mitoyo-hosp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junko Nakanishi
Organization Mitoyo General Hospital
Division name Department of pharmaceutical services
Zip code
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)

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 04 Month 22 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
2017 Year 03 Month 31 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000031030

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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