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
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
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
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
