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

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

http://www.hosp.u-toyama.ac.jp/medicaloncology/profile/kansatsu.html

Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name