UMIN-CTR Clinical Trial

Basic information
Public title	A research of L-Carnitine for general fatigue during chemothearpy in patients with advanced gastric cancer
Acronym	A research of L-Carnitine for general fatigue during chemothearpy in patients with advanced gastric cancer
Scientific Title	A research of L-Carnitine for general fatigue during chemothearpy in patients with advanced gastric cancer
Scientific Title:Acronym	A research of L-Carnitine for general fatigue during chemothearpy in patients with advanced gastric cancer
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the usefulness and safefy of L-carnitine for general fatigue during chemotherap in patients with advnced gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	BFI score
Key secondary outcomes	1)Nutritional assessment Alb, Hb, BMI, Amount of muscle 2)Tumor diameter 3)Adverse effect 4)Carnitine (total calnicin, free calnicin, acil calnicin)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	L-Carnitine group A 2000mg/day of L-Carnitine was administered on days 1 to 28. CDDP and TXT were intravenously administered on days 1 and 15, and S1 was orally administered day 1to 7 and 15 to 21. One course was 4 weeks and this treatment was repeated twice.
Interventions/Control_2	Control group L-Carnitine was not administered. CDDP and TXT were intravenously administered on days 1 and 15, and S1 was orally administered day 1to 7 and 15 to 21. One course was 4 weeks and this treatment was repeated twice.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients aged 20 years to 75 years 2.Patients with stage III gastric cancer 3.Patients receving neoadjuvant chemotherapy 4.Patients who can answer the queries 5.Patients who gaved informed consent
Key exclusion criteria	1.Patients who has allergy for L-carnitine 2.Pregnant patients or patients who hope pregnancy 3.Patients who are judged inappropriate by doctors
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Chikara Kunisaki
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	s0714@med.yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Chikara Kunisaki
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	s0714@med.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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	横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	17
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	2013 Year 07 Month 08 Day
Date of IRB	2013 Year 09 Month 27 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 28 Day
Last modified on	2019 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014191