UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043056 |
|---|---|
| Receipt number | R000049128 |
| Scientific Title | Effects of combination of alkalization therapy plus intravenous vitamin C treatment on chemotherapy outcomes in small cell lung cancer, retrospective study |
| Date of disclosure of the study information | 2021/01/19 |
| Last modified on | 2021/07/25 12:04:09 |
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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
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
reo-h@nifty.com
Sponsor or person
Institute
Japanese Society on Inflammation and Metabolism in Cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049128
