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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012956
Receipt No. R000015148
Scientific Title The evaluation of acute vascular damage induced by platinum-based chemotherapy
Date of disclosure of the study information 2014/01/25
Last modified on 2014/01/25

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Basic information
Public title The evaluation of acute vascular damage induced by platinum-based chemotherapy
Acronym Platinum-based chemotherapy and vascular damage
Scientific Title The evaluation of acute vascular damage induced by platinum-based chemotherapy
Scientific Title:Acronym Platinum-based chemotherapy and vascular damage
Region
Japan

Condition
Condition gynecological cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate the influence of PtChem on the vascular endothelial function and determine whether bezafibrate prevents endothelial dysfunction in gynecological cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The change of the flow-mediated dilation (FMD), serum pentraxin-3
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 The patients exhibiting hypertriglyceridemia during chemotherapy were administered Bezafibrate
Interventions/Control_2 No medication with bezafibrate for the patients exhibiting hypertriglyceridemia during chemotherapy.
Interventions/Control_3 the patients exhibiting normal triglyceride level.
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

Not applicable
Gender Female
Key inclusion criteria ovarian cancer or endometrial cancer patients who are going to receive adjuvant chemotherapy after surgical treatment.
Key exclusion criteria Participants who had received prior treatment for cancer and those with a history of cardiovascular disease (myocardial infarction, stroke, peripheral arterial thrombosis) or decompensated diabetes were excluded from this study. The exclusion criteria also included a history of clinically significant gastrointestinal, liver or gallbladder disease, treatment with lipid- or glucose-lowering agents and the use of hormone replacement therapy within the previous one year.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahid Ohmivhi
Organization Osaka Medical College
Division name Obstetrics and Gynecology
Zip code
Address 2-7 Daigaku-machi, Takatsuki city, Osaka
TEL +81-72-683-1221
Email gyn074@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Tanabe
Organization Osaka Medical College
Division name Obstetrics and Gynecology
Zip code
Address 2-7 Daigaku-machi, Takatsuki city, Osaka
TEL +81-72-683-1221
Homepage URL
Email gyn074@poh.osaka-med.ac.jp

Sponsor
Institute Dept of Obstetrics and Gynecology, Osaka Medical College
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research 24592535 (to A.T.) from the Ministry of Education, Science and Culture of Japan
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
2014 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results The administration of TC induced hypertriglyceridemia in 2/3 of the participants, with that of bezafibrate reduced the serum TG levels. Meanwhile, the decrease in %FMD induced by TC improved following treatment with bezafibrate. The serum pentraxin-3 level increased rapidly after TC and decreased following bezafibrate treatment.
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
2010 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 07 Day
Last follow-up date
2012 Year 11 Month 29 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2014 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 25 Day
Last modified on
2014 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015148

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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