UMIN-CTR Clinical Trial

Basic information
Public title	Study on effective prevention of chemotherapy-induced nausea and vomiting based on genetic polymorphism
Acronym	Clinical pharmacogenetics study for antiemetic therapy
Scientific Title	Study on effective prevention of chemotherapy-induced nausea and vomiting based on genetic polymorphism
Scientific Title:Acronym	Clinical pharmacogenetics study for antiemetic therapy
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the association between the effectiveness of standard prophylactic antiemetic therapy and genetic polymorphism in prevention of chemotherapy-induced emesis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Proportion of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr(during and post chemotherapy), acute phase;0-24hr, delayed phase 24-120hr]
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Breast cancer patients 2) Patients who receive the standard dose of AC combination 3) 20 years-old over at the time of giving informed consent 4) ECOG PS 0-2 5) Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows; WBC >= 3000/mm3 PLT >= 100000/mm3 AST <= 100 IU/L ALT <= 100 IU/L T-Bill <= 2.0 mg/dL S-Cr <= 1.5 mg/dL 6)Informed consent by the document
Key exclusion criteria	1) Known prior severe hypersensitivity to anthracyclines, cyclophosphamide, 5HT3 receptor antagonist, corticosteroids and NK-1 receptor antagonists 2) Patients who do not have enough whole body state to the antineoplastic agents treatment 3) Pregnant, breastfeeding or expecting woman 4) Patient with severe uncontrollable diabetes mellitus 5) Known symptomatic brain metastasis 6) Other clinical difficulties in this study
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yong-Il KIM
Organization	Seirei Hamamatsu General Hospital
Division name	Department of Medical Oncology
Zip code
Address	2-12-12, Sumiyoshi, Naka-ku, Hamamatsu, 430-8558, Japan
TEL	053-474-2222
Email	ykim@sis.seirei.or.jp

Public contact
Name of contact person	1st name Middle name Last name Daiki TSUJI
Organization	Univercity of Shizuoka
Division name	School of Pharmaceutical Science
Zip code
Address	52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL	054-264-5674
Homepage URL
Email	d-tsuji@u-shiuzoka-ken.ac.jp

Sponsor
Institute	Univercity of Shizuoka
Institute
Department

Funding Source
Organization	Univercity of Shizuoka
Organization
Division
Category of Funding Organization	Other
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	2012 Year 01 Month 25 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	Main results already published
Date of protocol fixation	2011 Year 10 Month 01 Day
Date of IRB	2011 Year 10 Month 31 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2014 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Blood samples are collected from breat cancer patients who received AC combination regimen. Relationship between genitic polymorphisms and antiemetic effect are assessed

Management information
Registered date	2012 Year 01 Month 25 Day
Last modified on	2021 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007957