UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012141 |
|---|---|
| Receipt number | 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 12:06:50 |
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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
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
s0714@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014191
