UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010656
Receipt number R000012466
Scientific Title Relationship between alcohol metabolism and chemotherapy induced emetic events
Date of disclosure of the study information 2013/05/07
Last modified on 2014/12/10 09:18:56

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Basic information

Public title

Relationship between alcohol metabolism and chemotherapy induced emetic events

Acronym

Relationship between alcohol metabolism and chemotherapy induced emetic events(ACHIEVE study)

Scientific Title

Relationship between alcohol metabolism and chemotherapy induced emetic events

Scientific Title:Acronym

Relationship between alcohol metabolism and chemotherapy induced emetic events(ACHIEVE study)

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery Adult

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The correlation between habitual alcohol consumption and CINV has been reported but it would be worthwhile to ascertain the underlying mechanism, specifically whether Japanese subjects, 40% of whom lack one of the alleles of ALDH2 gene which is related to the alcohol-metabolizing enzyme, are particularly supposed to be susceptible to CINV. To elucidate the mechanism of CINV, as our primary endpoint, we examined whether genetic polymorphism of ALDH2 and habitual alcohol consumption are related to CR. As the secondary endpoint, we investigated the relationships between CC( complete control) and CRs, which are divided into the early, delayed and all phases, and those between ALDH2 genetic polymorphisms and habitual alcohol consumption in women with breast cancer who received an AC therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We investigate the relationship between CR (complete response) and genetic polymorphism of ALDH2 to elucidate the mechanism of CINV whether ALDH2 and habitual alcohol consumption are related to CR.

Key secondary outcomes

We investigate the relationships between CC( complete control) and CRs, which are divided into the early, delayed and all phases, and those between ALDH2 genetic polymorphisms and habitual alcohol consumption in women with breast cancer who received an AC therapy.


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

20 years-old <=

Age-upper limit

55 years-old >

Gender

Female

Key inclusion criteria

The subjects were breast cancer patients treated with first course of FEC (Fluorouracil (5-FU), epirubicin and cyclophosphamide )as one of AC therapies, at the outpatient clinic of our hospital between 2012 and 2014 and who met the following criteria: 20 to 55 years of age, female, disease at stages I-III and a performance status (PS) of 0-1.

Key exclusion criteria

Patients who are judged to be inappropriate for the study by the investigator.

Target sample size

81


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsue Saito

Organization

Juntendo University Hospital

Division name

Department of Breast Oncology

Zip code


Address

3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421

TEL

03-3813-3111

Email

mitsue@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshitaka Uomori

Organization

Juntendo University Hospital

Division name

Department of Breast Oncology

Zip code


Address

3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421

TEL

03-3813-3111

Homepage URL


Email

tuomori@juntendo.ac.jp


Sponsor or person

Institute

Juntendo Clinical Research Support Center

Institute

Department

Personal name



Funding Source

Organization

Department of Breast Oncology,Juntendo University Hospital

Organization

Division

Category of Funding Organization

Self funding

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

順天堂大学医学部附属順天堂医院(東京)


Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 07 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

No longer recruiting

Date of protocol fixation

2012 Year 12 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 07 Day

Last follow-up date

2014 Year 09 Month 01 Day

Date of closure to data entry

2014 Year 09 Month 01 Day

Date trial data considered complete

2014 Year 09 Month 01 Day

Date analysis concluded

2014 Year 09 Month 01 Day


Other

Other related information

ALDH2 gene is investigated using 0.5ml of residual blood from regular check-up blood testing sample of each breast cancer patient.


Management information

Registered date

2013 Year 05 Month 07 Day

Last modified on

2014 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012466


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name