UMIN-CTR Clinical Trial

Basic information
Public title	Effects of combination of alkalization therapy plus intravenous vitamin C treatment on chemotherapy outcomes in small cell lung cancer, retrospective study
Acronym	Alkalization therapy plus vitamin C with chemotherapy in small cell lung cancer
Scientific Title	Effects of combination of alkalization therapy plus intravenous vitamin C treatment on chemotherapy outcomes in small cell lung cancer, retrospective study
Scientific Title:Acronym	Alkalization therapy plus vitamin C with chemotherapy in small cell lung cancer
Region	Japan

Condition
Condition	Small cell lung cancer
Classification by specialty	Pneumology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Our study purpose is to investigate the effect of alkalization therapy plus intravenous vitamin C treatment on chemotherapy in small cell lung cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival (OS) from diagnosis Urine pH after alkalization therapy plus intravenous vitamin C treatment
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with small cell lung cancer who were treated at Karasuma Wada Clinic between January 2011 and December 2018. Patients who received alkalization therapy plus intravenous vitamin C treatment. Patients who agreed informed consent.
Key exclusion criteria	Patients who could not follow the alkalization therapy and/or intravenous vitamin C treatment.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Reo Middle name Last name Hamaguchi
Organization	Japanese Society on Inflammation and Metabolism in Cancer
Division name	Japanese Society on Inflammation and Metabolism in Cancer, working group
Zip code	604-0842
Address	119 Nishioshikouji-cho, Higashinotouin-nishiiru, Oshikouji-street, Nakagyo-ku, Kyoto 604-0842, Japan
TEL	+81-75-223-3223
Email	reo-h@nifty.com

Public contact
Name of contact person	1st name Reo Middle name Last name Hamaguchi
Organization	Japanese Society on Inflammation and Metabolism in Cancer
Division name	Japanese Society on Inflammation and Metabolism in Cancer, working group
Zip code	604-0842
Address	119 Nishioshikouji-cho, Higashinotouin-nishiiru, Oshikouji-street, Nakagyo-ku, Kyoto 604-0842, Japa
TEL	+81-75-223-3223
Homepage URL
Email	reo-h@nifty.com

Sponsor
Institute	Japanese Society on Inflammation and Metabolism in Cancer
Institute
Department

Funding Source
Organization	Japanese Society on Inflammation and Metabolism in Cancer
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	The Japan-Multinational Trial Organization
Address	2-14-10-3F Marunouchi, Naka-ku, Nagoya, Aichi
Tel	052-218-3301
Email	info@jmto.org

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	2021 Year 01 Month 19 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	33
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 09 Month 20 Day
Date of IRB	2018 Year 09 Month 20 Day
Anticipated trial start date	2021 Year 01 Month 19 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study was retrospectively conducted to investigate the effect of alkalization therapy plus intravenous vitamin C treatment on chemotherapy in small cell lung cancer patients. This study is comprehensively included in "Investigation for survival factors of cancer patients analyzed by the data science method" approved by IRB of the JMTO.

Management information
Registered date	2021 Year 01 Month 19 Day
Last modified on	2021 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049128