UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035659 |
|---|---|
| Receipt number | R000040611 |
| Scientific Title | Effects of alkalization therapy on chemotherapy in metastatic or recurrent pancreatic cancer, retrospective study |
| Date of disclosure of the study information | 2019/01/24 |
| Last modified on | 2020/01/31 10:22:26 |
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Basic information
Public title
Effects of alkalization therapy on chemotherapy in metastatic or recurrent pancreatic cancer, retrospective study
Acronym
Alkalization therapy with chemotherapy in advanced pancreatic cancer
Scientific Title
Effects of alkalization therapy on chemotherapy in metastatic or recurrent pancreatic cancer, retrospective study
Scientific Title:Acronym
Alkalization therapy with chemotherapy in advanced pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our study purpose is to investigate the effect of alkalization therapy on chemotherapy in metastatic or recurrent pancreatic 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 or recurrence
OS from the start of alkalization therapy
Urine pH before and after alkalization therapy
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 metastatic or recurrent pancreatic cancer who were treated at the Karasuma Wada Clinic between April 2015 and December 2017.
Patients who received alkalization therapy.
Patients who agreed written informed consent.
Key exclusion criteria
Patients who could not follow the alkalization therapy and/or visited our clinic less than 3 times.
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, Japan
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
| 2019 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
http://www.scim.or.jp
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
28
Results
The mean urine pH was significantly higher after the alkalization therapy (6.85 +- 0.74 vs. 6.39 +- 0.92; p < 0.05).
The median overall survival from the start of alkalization therapy of the patients with high urine pH (< 7.0) was significantly longer than those with low urine pH (<= 7.0)(16.1 vs. 4.7 months; p < 0.05).
Results date posted
| 2020 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients analyzed included 15 men and 13 women, and the mean age at the start of the alkalization therapy was 63.6 (range, 47 to 82) years. Daily living ability of each patient was evaluated according to the Eastern Cooperative Oncology Group scale of Performance Status (PS). Two patients had PS 0, 24 had PS 1, and 1 each had PS 2 and 3. Nineteen patients were clinical stage IV and 9 had recurrent disease. Twenty-three patients had received chemotherapy before their first visit to our clinic, whereas 5 had not. Twenty out of the 28 patients took supplementary bicarbonate. Patient characteristics are presented in Table 1.
Participant flow
A total of 50 patients with metastatic or recurrent pancreatic cancer were treated at the Karasuma Wada Clinic between April 2015 and December 2017. Alkalization therapy was initiated in all patients. If patients refused to follow an alkaline diet owing to their dietary preference, they were excluded from the study population. Therefore, 22 patients who did not follow the alkalization therapy or visited our clinic less than 3 times were excluded from the study. Finally, 28 pancreatic cancer patients who were given alkalization therapy together with chemotherapy were analyzed.
Adverse events
no special notes
Outcome measures
Data were analyzed on June 30, 2019. The mean urine pH of each patient was compared using the paired t-test between before and after alkalization therapy. OS from either the time of diagnosis or recurrence and the start of alkalization therapy was calculated using Kaplan-Meier estimates, and compared between patients with a urine pH of 7.0 or less and those with a urine pH of higher than 7.0. OS from the start of the alkalization therapy was also compared between patients with a urine delta-pH of 1.0 or less and those with a urine delta-pH of more than 1.0. OS from the time of initiation of the alkalization therapy were also compared among patients with a urine delta-pH of 0 or less, those with a delta-pH of more than 0 but less than or equal to 1.0, and those with a delta-pH of more than 1.0. Urine delta-pH was calculated by subtracting the mean urine pH before alkalization therapy from the mean urine pH after alkalization therapy. Mean data set values were presented with +- standard deviation. All p-values were two-sided and p-values of less than 0.05 were considered to indicate a statistically significant difference between two groups.
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
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | 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 on chemotherapy in advanced pancreatic cancer patients. Currently, data analysis is in progress.
In addition, 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
| 2019 | Year | 01 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040611
