UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036126
Receipt number R000041155
Scientific Title Effects of alkalization therapy in metastatic or recurrent pancreatic cancer: a case-control study
Date of disclosure of the study information 2019/03/11
Last modified on 2020/09/30 12:58:23

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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 or person

Institute

Karasuma Wada Clinic

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041155


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name