UMIN-CTR Clinical Trial

Basic information
Public title	Measurement of saliva drug concentration in patients undergoing cancer chemotherapy
Acronym	Measurement of saliva drug concentration in patients undergoing cancer chemotherapy
Scientific Title	Measurement of saliva drug concentration in patients undergoing cancer chemotherapy
Scientific Title:Acronym	Measurement of saliva drug concentration in patients undergoing cancer chemotherapy
Region	Japan

Condition
Condition	Gastrointestinal malignant tumor, Breast cancer
Classification by specialty	Gastrointestinal surgery Breast surgery Obsterics and gynecology Oral surgery Dental medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	I investigate the influence of the presence of the drug shift in the oral cavity of the anticancer agent and the side effect appearance by measuring the drug level out of saliva of the cancer chemotherapy enforced patient about a side effect of use of anticancer agent appearance of oral mucositis and the taste disorder qualitatively and quantitatively .
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	At the time of the intravenous feeding dosage end of the anticancer agent, We collect saliva seven days later for 72 hours for 24 hours. We measure the drug blood concentration of saliva which we collected qualitatively and quantitatively using liquid chromatograph - tandem type mass spectrometer (LC/MS/MS).
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.Adequate organ functiont 2.Psrformance status:0-2 3.Written informed consent prior to sutudy-spe cific screening procedure
Key exclusion criteria	Cannot collect saliva by oneself.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Motohiko Middle name Last name Sano
Organization	Saitama Medical Center Saitama Medical University
Division name	department of pharmacy
Zip code	350-8550
Address	1981 Kamoda, Kawagoe, Saitama
TEL	049-228-3599
Email	msano@saitama-med.ac.jp

Public contact
Name of contact person	1st name Motohiko Middle name Last name Sano
Organization	Saitama Medical Center Saitama Medical University
Division name	department of pharmacy
Zip code	350-8550
Address	1981 Kamoda, Kawagoe, Saitama
TEL	049-228-3599
Homepage URL
Email	msano@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center Saitama Medical University
Institute
Department

Funding Source
Organization	none
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	Saitama Medical Center Saitama Medical University
Address	1981 Kamoda, Kawagoe, Saitama
Tel	049-228-3400
Email	irbsmc@saitama-med.ac.jp

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	2017 Year 03 Month 30 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	6
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	Terminated
Date of protocol fixation	2017 Year 03 Month 25 Day
Date of IRB	2017 Year 06 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 25 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2017 Year 03 Month 25 Day
Last modified on	2020 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030358