UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017660
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tkashii@med.u-toyama.ac.jp

Sponsor
Institute Toyama University Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020470

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.