UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012956
Receipt number 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 08:11:52

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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

Obstetrics 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 or person

Institute

Dept of Obstetrics and Gynecology, Osaka Medical College

Institute

Department

Personal name



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

Value
https://center6.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