UMIN-CTR Clinical Trial

Public title

The exploratory study for the biological effects of metformin on endometrial cancer: effect to cell cycle, MAPK, and AMPK/mTOR signal pathway

Acronym

The exploratory study for the effects of metformin on endometrial cancer

Scientific Title

The exploratory study for the biological effects of metformin on endometrial cancer: effect to cell cycle, MAPK, and AMPK/mTOR signal pathway

Scientific Title:Acronym

The exploratory study for the effects of metformin on endometrial cancer

Region

Japan

Condition

endometrial carcinoma

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

It is unclear whether therapeutic doses of metformin are effective for patients with endometrial cancer.
To confirm direct and indirect effect of metformin for patients with endometrial cancer.

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

To evaluate the effects of metformin, cell proliferation activity and signal pathway were compared between pre- and post-treatment samples.
1) Cell proliferation was evaluated by immunohistochemistry using antibody of Ki-67 (positive for all cell cycle except for G0) and topoisomerase II A(positive at S/G2/M phase)
2) Findings related to the MAPK, AMPK and mTOR signaling pathways and cell cycle proteins were compared by Western blot analysis.

Key secondary outcomes

To evaluate the effect for endocrine factors ( HOMA-R, insulin, glucose, leptin, adiponectin)

To evaluate the antiproliferative effect of patients serum obtained before and after treatment

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

Metformin (an initial dose of 750 mg/day, increased by 750 mg every week up to 1500 or 2250 mg/day) was administered to patients with endometrial cancer prior to surgery.
Endometrial tissue was obtained before and during metformin therapy via endometrial biopsy for diagnosis and hysterectomy, respectively. Patients undergo blood sample collection periodically for biomarker analysis.

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

70

years-old

>

Gender

Female

Key inclusion criteria

(1) Histrogically confirmed grade 1-2 endometrioid adenocarcinoma
(2) myometrium invasion was ruled out by MRI
(3)performance status of 0
(4) serum creatinine <0.8mg/dl
(5) A case without hypersensitivity for this treatment use medicine
(6) The case that written informed consent was obtained before participation

Key exclusion criteria

(1) The case with a history of the hypersensitivity that is serious for this study use medicine or the drug allergy
(2)A history of the lactic acidosis
(3)Patients on dialysis
(4)Shock, failure heart, myocardial infarction, a cardiovascular injury including the pulmonary embolism
(5)Excessive alcohol intake
(6)Hepatic dysfunction
(7) A history of the thrombosis
(8)A case with the psychic disturbance that it seems that we need in the treatment or treatment with antimental medicine
(9) Patients with diabetes
(10)A case with the double cancer of the activity
(11)In addition, the case that the chief physician judged to be inadequate.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	akira mitsuhahsi

Organization

Graduate School of Medicine, Chiba University

Division name

Reproductive Medicine

Zip code

Address

1-8-1 inohana chuoku chiba japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	akira mitsuhashi

Organization

Graduate School of Medicine, Chiba University

Division name

Reproductive Medicine

Zip code

Address

TEL

043-226-2121

Homepage URL

Email

Institute

Graduate School of Medicine, Chiba University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

01

Month

11

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

Enrolling by invitation

Date of protocol fixation

2010

Year

04

Month

27

Day

Date of IRB

Anticipated trial start date

2010

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

01

Month

10

Day

Last modified on

2012

Year

10

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005770