UMIN-CTR Clinical Trial

Basic information
Public title	Effects of alkalization therapy in metastatic or recurrent pancreatic cancer: a case-control study
Acronym	Effects of alkalization therapy in metastatic or recurrent pancreatic cancer
Scientific Title	Effects of alkalization therapy in metastatic or recurrent pancreatic cancer: a case-control study
Scientific Title:Acronym	Effects of alkalization therapy in metastatic or recurrent pancreatic cancer
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study is to investigate the effects of alkalization therapy consisting of alkaline diet and bicarbonate compared with the control group.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival (OS)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Intervention group: Metastatic or recurrent pancreatic cancer patients who treated with alkalization therapy consisting of alkaline diet and bicarbonate Control group: Metastatic or recurrent pancreatic cancer patients who did not receive alkalization therapy
Key exclusion criteria	Patients who refused to participate the study by opt-out.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hiromi Middle name Last name Wada
Organization	Karasuma Wada Clinic
Division name	Oncology
Zip code	604-0845
Address	Yasaka Karasuma-oike Building 2F, Nijodencho 538, Karasuma-dori Oike Noboru, Nakagyo-ku, Kyoto 604-0845, Japan
TEL	075-213-0080
Email	wadah@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Reo Middle name Last name Hamaguchi
Organization	Karasuma Wada Clinic
Division name	Oncology
Zip code	604-0845
Address	Nijodencho 538, Karasuma-dori Oike Noboru, Nakagyo-ku, Kyoto, Japan
TEL	075-213-0080
Homepage URL
Email	reo-h@nifty.com

Sponsor
Institute	Karasuma Wada Clinic
Institute
Department

Funding Source
Organization	Karasuma Wada Clinic
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	Ethics Committe, Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital
Address	Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501
Tel	075-753-4683
Email	ethcom@kuhp.kyoto-u.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	2019 Year 03 Month 11 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	125
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	Completed
Date of protocol fixation	2018 Year 10 Month 26 Day
Date of IRB	2018 Year 10 Month 26 Day
Anticipated trial start date	2018 Year 12 Month 31 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	The study is case-control study that compare alkalization therapy group (Karasuma Wada Clinic) with control group (Kyoto University).

Management information
Registered date	2019 Year 03 Month 08 Day
Last modified on	2020 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041155