UMIN-CTR Clinical Trial

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
Name of lead principal investigator	1st name Shinichi Middle name Last name Toyooka
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Clinical Genomic Medicine
Zip code	700-8558
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
Name of contact person	1st name Mototsugu Middle name Last name 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	700-8558
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	Okayama University Hospital IRB
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
Tel	086-235-6503
Email	mae6605@adm.okayama-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	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	No longer recruiting
Date of protocol fixation	2014 Year 07 Month 15 Day
Date of IRB	2014 Year 07 Month 15 Day
Anticipated trial start date	2014 Year 07 Month 16 Day
Last follow-up date	2019 Year 03 Month 31 Day
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	2020 Year 08 Month 05 Day

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