UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017660 |
|---|---|
| Receipt number | R000020470 |
| Scientific Title | A comparison of fatigue in two groups of cancer patients administered or not administered carnitine after the cisplatin administration: A non-blinded, randomized controlled study |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2015/05/24 16:40:36 |
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Basic information
Public title
A comparison of fatigue in two groups of cancer patients administered or not administered carnitine after the cisplatin administration: A non-blinded, randomized controlled study
Acronym
The study about fatigue mitigation after the cisplatin administration in cancer patients.
Scientific Title
A comparison of fatigue in two groups of cancer patients administered or not administered carnitine after the cisplatin administration: A non-blinded, randomized controlled study
Scientific Title:Acronym
The study about fatigue mitigation after the cisplatin administration in cancer patients.
Region
| Japan |
Condition
Condition
Cancer patients who will receive chemotherapy including cisplatin (The target will be all types of tumors.)
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of fatigue mitigation by measuring the carnitine concentrations in plasma and urine after the carnitine administration in scheduled chemotherapy including cisplatin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Carnitine concentrations in plasma and urine
Fatigue scale (FACIT-F)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group
Day1: Levocarnitine injection 3000mg/day
Day2-7: Levocarnitine oral solution 3000mg/day
Interventions/Control_2
Control group
An individual patient receives the best and standard treatment, selected by a physician, against fatigue after the cisplatin administration.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Cancer patients who will receive chemotherapy including cisplatine
2)PS(ECOG)0-1
3)Patients who agree with the documents
4)Patient ages at the point of agreement is under 75 years old
Key exclusion criteria
1)Prognosis less than 3 months
2)Hemoglobin < 10g/dL
3)Less than one month after operation or radiotherapy
4)Ineligible judged by physician other than above
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuhiko Kashii |
Organization
Toyama University Hospital
Division name
Department of Medical Oncology
Zip code
Address
2630 Sugitani, Toyama-shi, Toyama pref. 930-0194 Japan
TEL
076-434-7808
tkashii@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuhiko Kashii |
Organization
Toyama University Hospital
Division name
Department of Medical Oncology
Zip code
Address
2630 Sugitani, Toyama-shi, Toyama pref. 930-0194 Japan
TEL
076-434-7808
Homepage URL
tkashii@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 24 | Day |
Last modified on
| 2015 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020470
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
