UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the remaining alcohol after intravenous injection of paclitaxel by analysis of expired gas and examination of the method for decreasing the remaining alcohol
Title of the study (Brief title)	Evaluation of the remaining alcohol after intravenous injection of paclitaxel by analysis of expired gas and examination of the method for decreasing the remaining alcohol
Region	Japan

Condition
Condition	Malignancy
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is the evaluate the remaining alcohol after intravenous injection of paclitaxel by analysis of expired gas and examinaion of the method for decreasing the remaining alcohol.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Breath alcohol concentration
Key secondary outcomes	Subjective symptom

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Measuring the breath alcohol concentration 1-3 times after an intravenous injection of paclitaxel Measuring the breath alcohol concentration similarly after drinking water
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient who get treatment with paclitaxel
Key exclusion criteria	The patient by whom consent can't be obtained
Target sample size	30

Research contact person
Name of lead principal investigator	Nao Odagri
Organization	Hirosaki University School of Medicine and Hospital
Division name	Pharmaceutical department
Address	53 Hon-cho, Hirosaki, Aomori
TEL	0172-33-5111
Email	odagiri-hki@umin.ac.jp

Public contact
Name of contact person	Nao Odagri
Organization	Hirosaki University School of Medicine and Hospital
Division name	Pharmaceutical department
Address	53 Hon-cho, Hirosaki, Aomori
TEL	0172-33-5111
Homepage URL
Email	odagiri-hki@umin.ac.jp

Sponsor
Institute	Hirosaki University School of Medicine and Hospital Pharmaceutical department
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 04 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 28 Day
Anticipated trial start date	2016 Year 03 Month 28 Day
Last follow-up date	2016 Year 11 Month 30 Day
Date of closure to data entry	2016 Year 12 Month 11 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 11 Day
Last modified on	2016 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025190