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

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, Japan

TEL

+81-75-223-3223

Homepage URL


Email

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name