UMIN-CTR Clinical Trial

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

cancer and sarcoma

Classification by specialty

Hematology and clinical oncology	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery
Chest surgery	Endocrine surgery	Breast surgery
Obstetrics and Gynecology	Dermatology	Oto-rhino-laryngology
Orthopedics	Urology	Oral surgery

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Okayama University Hospital

Institute

Department

Personal name

Organization

Okayama University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

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

Date of disclosure of the study information

2014

Year

07

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

07

Month

28

Day

Last modified on

2020

Year

08

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016406