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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014689
Receipt No. R000016406
Scientific Title Study about the efficacy of metformin to immune function in cancer patients.
Date of disclosure of the study information 2014/07/28
Last modified on 2019/05/03

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Basic information
Public title Study about the efficacy of metformin to immune function in cancer patients.
Acronym Study about the efficacy of metformin to immune function in cancer patients.
Scientific Title Study about the efficacy of metformin to immune function in cancer patients.
Scientific Title:Acronym Study about the efficacy of metformin to immune function in cancer patients.
Region
Japan

Condition
Condition cancer and sarcoma
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Endocrine surgery Breast surgery
Obsterics and gynecology Dermatology Oto-rhino-laryngology
Orthopedics Urology Oral surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To examine the effect of metformin on T cells in vivo by administering metformin to malignancies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ability to produce cytokines (IL-2, TNF alpha, IFN gamma) and differentiation (memory, regulatory etc.) in peripheral blood T cells.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administering metformin.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Subjects who received a full explanation of the study and gave a written informed consent.
2. Subjects who can complain abnormal and subjective symptoms if they suffer from them during the study.
Key exclusion criteria 1. Subjects who have received insulin therapy for diabetes mellitus.
2. Subjects who have the previous medical history of lactic acidosis.
3. Subjects who have received hemodialysis.
4. Subjects who have serious hepatic dysfunction.
5. Subjects who have the previous medical history of shock status, heart failure, cardiac infarction, pulmonary infarction and hypoxia.
6. Subjects who have drinking habit.
7. Subjects who are dehydration,
8. Subjects who have the previous medical history of severe ketosis, diabetic coma and type 1 diabetes.
.
9. Subjects who have severe infection and serious trauma.
10. Subjects who are malnutrition, starvation, adrenal insufficiency and pituitary gland dysfunction.
11. Pregnant wouman
12. Subjects who are allergic to medicines.
13. Subjects who have been enrolled in the other clinical trials within last 4 months before the administration of metformin and administered any investigational new drugs.
14. Other subjects who are judged to be ineligible in this trial by the investigator.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shinichi Toyooka
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Clinical Genomic Medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL 086-235-7436
Email toyooka@md.okayama-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Mototsugu Watanabe
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of General Thoracic Surgery and Breast and Endocrinological Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL 086-235-7265
Homepage URL
Email mowatanabe@s.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Okayama University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 岡山大学病院(岡山県)
Okayama University Hospital(Okayama)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 28 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
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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2019 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016406

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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