UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011596 |
|---|---|
| Receipt number | R000013558 |
| Scientific Title | The relationship with carnitine pharmacokinetics and fatigue after cisplatine administration in cancer patients |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2015/08/31 16:36:47 |
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Basic information
Public title
The relationship with carnitine pharmacokinetics and fatigue after cisplatine administration in cancer patients
Acronym
The relationship with carnitine pharmacokinetics and fatigue after cisplatine administration in cancer patients
Scientific Title
The relationship with carnitine pharmacokinetics and fatigue after cisplatine administration in cancer patients
Scientific Title:Acronym
The relationship with carnitine pharmacokinetics and fatigue after cisplatine administration in cancer patients
Region
| Japan |
Condition
Condition
Cancer patients of admission in scheduled chemotherapy including cisplatine (The target will be all type of tumor)
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate of relationship with fatigue and carnitine concentrations in plasma and urine in cancer patients after chemotherapy including cisplatine.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
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
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Cancer patients of admission in scheduled chemotherapy including cisplatine
2)PS(ECOG)0-1
3)Patients who agree with the documents
4)Patient ages at the point of agreement is less than 75 years old
Key exclusion criteria
1)Patients of prognosis is less than 3 months
2)Hemoglobin < 10g/dL
3)Less than one month after operation or radiotherapy
4)Judgment of ineligible by physician excluding the above
Target sample size
20
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
http://www.hosp.u-toyama.ac.jp/medicaloncology/profile/kansatsu.html
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
| 2013 | Year | 09 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim is to evaluate of relationship with fatigue and carnitine concentrations in plasma and urine in cancer patients after chemotherapy including cisplatine.
Management information
Registered date
| 2013 | Year | 08 | Month | 28 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013558
