UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Piolt study of usefulness of analysis of genetic polymorphism of aldehyde dehydrogenase 2 (ALDH2) in safety of paclitaxel for the patients with alcohol intolerance
Title of the study (Brief title)	Role of genetic polymorphism of aldehyde dehydrogenase 2 (ALDH2) in the alcohol-related toxicity of paclitaxel
Region	Japan

Condition
Condition	Breast cancer, gastric cancer, ovarian cancer, non-small cell lung cancer, head and neck cancer, esophageal cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We analyze genetic polymorphism of ALDH2 in patients with malignant disease (breast cancer, gastric cancer, ovarian cancer, non-small cell lung cancer, head and neck cancer, esophageal cancer) to see the correlation between genetic status of ALDH2(ALDH2*1/*1 and ALDH2*1/*2 ) and frequency and grade of alcohol-related toxicity of paclitaxel.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Completion rate of two cycles of weekly paclitaxel
Key secondary outcomes	1) Rate of genetic polymorphism of ALDH2, 2) frequency and grade of alcohol associated symptoms after paclitaxel injection, 3)time course of breath alcohol concentration (BAC)

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients with ALDH2*1/*1 will be injected paclitaxel for 1 hour, and patients with ALDH2*1/*2 will be injected it for three hours.Frequency and grade of alcohol associated symptoms will be checked after paclitaxel injection.
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	1)ECOG scale: PS0-2 2)Patient with enough feasibility for planned chemotherapy which contains paclitaxcel (hematological, liver, renal, cardiopulmonary function) 3)Patient suspected to have intolerance for alcohol on medical interview, e.g. patient who feel uneasy about taking a glass of beer ( about 180ml) 4)Written informed consent
Key exclusion criteria	1)Pregnancy, the possibility of pregnancy or breast feeding. 2)Patients unable to take paclitaxcel because of significant cardiovascular abnormalities, renal dysfunction, hepatic insufficiency, uncontrolled hypertension, uncontrolled diabetes, bleeding tendency, active interstitial pneumonia ,etc. 3)Febrile patients who are suspected to be infected. 4)Prior treatment with paclitaxcel 5)Patients unable to comply with the protocol, in the opinion of the investigator. 6)Other contraindication to paclitaxcel. (1)severe myelosuppression (2)Known hypersensitivity to paclitaxcel or drugs which contain polyoxyethylene caster oil (e.g. ciclosporin injection). (3) Patient taking disulfiram, cyanamide, carmofur, and procarbazine hydrochloride.
Target sample size	20

Research contact person
Name of lead principal investigator	Toshinari Yagi
Organization	Osaka International Cancer Institute
Division name	Department of Clinical Oncology
Address	3-1-69 Otemae, Chuo-ku,Osaka 541-8567 Japan
TEL	06-6945-1181
Email	yagi-to@mc.pref.osaka.jp

Public contact
Name of contact person	Toshinari Yagi
Organization	Osaka International Cancer Institute
Division name	Department of Clinical Oncology
Address	3-1-69 Otemae, Chuo-ku,Osaka 541-8567 Japan
TEL	06-6945-1181
Homepage URL
Email	yagi-to@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	大阪国際がんセンター大阪府）

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 21 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2016 Year 01 Month 14 Day
Date of closure to data entry	2016 Year 01 Month 14 Day
Date trial data considered complete	2016 Year 01 Month 14 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007/s12282-018-0918-9
Results
Other related information

Management information
Registered date	2012 Year 03 Month 30 Day
Last modified on	2018 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009002