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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012141
Receipt No. R000014191
Scientific Title A research of L-Carnitine for general fatigue during chemothearpy in patients with advanced gastric cancer
Date of disclosure of the study information 2013/12/01
Last modified on 2019/11/06

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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/ctr_e/ctr_view.cgi?recptno=R000014191

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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