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Exploratory study on the anti-proliferative effects of metformin on endometrial cancer

Exploratory study on the anti-proliferative effects of metformin on endometrial cancer

Habu Yuji

Chiba University Hospital

1-8-1 Inohana Chuo-ku Chiba Japan

ayta1689@chiba-u.jp

Habu Yuji

Chiba University Hospital

1-8-1 Inohana Chuo-ku Chiba Japan

+81-43-226-2121

ayta1689@chiba-u.jp

Recruiting

Feb. 04, 2016

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

basic science

1.Histologically confirmed grade 1-2 endometrioid adenocarcinoma
2.BMI over 25 and positive for insulin resistance
3.Over 20 years and under 60 years of age
4.Eastern Cooperative Oncology Group Performance status 0
5.Patient who are ready to provide written informed consent

1. Prior medical history of chemical sensitivity to metformin
2. Serum creatinine over1.0 mg/dl
3.History of lactic acidosis
4.Patients undergoing dialysis
5.Shock, cardiac arrest, cardiac infarction, thrombosis of the lung, or severe cardiovascular and/or lung damage
6.Ingestion of excessive amounts of alcohol
7.Elevated levels of AST(GOT), ALT(GPT) (over2 times upper limit of normal)
8.History of thrombosis
9.Mental illness that may require the administration of antipsychotics
10.Diabetes mellitus that requires medication
11.HbA1c over 8.0
12.Concomitant malignancies
13.Determined to be ineligible by the physician in charge for any other reason

Female

Endometria cancer

Patients will receive a daily dose of metformin (initial dose, 500 mg/day; increased weekly up to 2250 mg/day in the absence of any adverse effects).

106

To evaluate the effect of metformin on H19 expression in endometrial cancer tissue

1. To evaluate the effect of metformin on the activity of aromatase, expression of let7, c myc Hmga2, lmp in endometrial cancer tissue
2. To evaluate the effect of metformin on DNA methylation in endometrial cancer tissue
3. To evaluate the effect of metformin on the expression of biomarkers in the endometrium.
Differences in Ki67 and Topoisomerase II expression using immunohistochemistry.
Expression of PhosphorERK, PhosphorAKT, phosphor AMPK, phosphor-rpS6, cyclin D1 using western blot analysis
4. Evaluation of toxicity

+81-43-226-2616

No

none