UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025715 |
|---|---|
| Receipt number | R000028392 |
| Scientific Title | Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water |
| Date of disclosure of the study information | 2017/01/17 |
| Last modified on | 2023/01/23 12:47:37 |
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Basic information
Public title
Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water
Acronym
Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water
Scientific Title
Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water
Scientific Title:Acronym
Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water
Region
| Japan |
Condition
Condition
ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
I consider whether Depp Ocean Water(DOW) is effective for immunocompetence improvement after the treatment of the ovarian cancer patient.
There is a cell group taking regular immunoresponse, negative immunoresponse in the living body. When negative immunoresponse is strong, it is expected that a relapse rate after the first treatment rises, but the recurrence is more likely to be controlled when regular immunoresponse continues it. For 24 months, I include it and do the PFI in patients performed induction of remission of in the ovarian cancer first time at least with an observation period between three years. The parameter of the living body of immunity considers I change, and how it contributes to convalescence improvement by drinking DOW this time. I perform group distinction of an ovarian cancer patient and judge an effect of DOW. The main end-point assumes it a parameter (CD3.CD4.CD8.CD12.CD11b.CD19.CD16.CD56) of immunity. I do the secondary end-point with disease-free survival, all duration of survival.
Basic objectives2
Others
Basic objectives -Others
Ovarian cancer recurrence protective efficacy of DOW
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Parameter (CD3.CD4.CD8.CD12.CD11b.CD19.CD16.CD56) of the host of immunity
Key secondary outcomes
PFS OS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A group (the DOW administrated group): I drink Depp Ocean Water(DOW) 500 ml/day in normal life. I perform a study from a registration start with a period to being finished.
Interventions/Control_2
B group (control group): I drink 500 ml/day of placebo water in normal life. I perform a study from a registration start with a period to being finished.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
We I choose the patient who does not have an exclusion item among the ovarian cancer patients whom the 80-year-old first induction of remission was got from from 50 years old that received the hospital obstetrics and gynecology department attached to the Kochi University medical department.
Key exclusion criteria
1.Person (immunosuppressive drug, adrenal cortical hormone) who takes the drug which may influence the endpoint
2.The person who needs water restrictions due to the disease including heart failure, the renal insufficiency
3.The person who participates in other clinical trials
4.One having serious complications including renal insufficiency, liver failure, the heart failure
5.One having the high blood pressure that is not controlled by medical treatment
6.One having lower limbs vein thrombosis
7.One having lower limbs lymphedema
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nagamasa |
| Middle name | |
| Last name | Maeda |
Organization
Kochi Medical School
Division name
Obstetrics and gynecology
Zip code
783-8505
Address
okoh,Nannkoku,Kochi,Japan
TEL
088-880-2383
maedan@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ushiwaka |
Organization
Kochi Medical School
Division name
Obstetrics and gynecology
Zip code
783-8505
Address
okoh,Nannkoku,Kochi,Japan
TEL
088-880-2383
Homepage URL
takashi-u@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Muroto, Kochi deep-ocean water functionality evaluation business
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Medical School
Address
Kohasu Okocyo Nangokushi Kochi
Tel
088-866-5811
is21@kochi-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
| 2017 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
http://www.kochi-u.ac.jp/kms/fm_obstr/index.htm
Publication of results
Unpublished
Result
URL related to results and publications
http://www.kochi-u.ac.jp/kms/fm_obstr/index.htm
Number of participants that the trial has enrolled
10
Results
Unanalyzed
Results date posted
| 2021 | Year | 07 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
ovarian cancer
Participant flow
Recruit after treatment
Adverse events
none
Outcome measures
OS PFS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Currently recruiting on a limited basis.
Management information
Registered date
| 2017 | Year | 01 | Month | 17 | Day |
Last modified on
| 2023 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028392
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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