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

JRCT ID: jRCTs031180339

Registered date:18/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Endometria cancer
• Date of first enrollment: 23/05/2016
• Target sample size: 15
• Study type: Interventional
• Intervention(s): 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).

Outcome(s)

• Primary Outcome: To evaluate the effect of metformin on H19 expression in endometrial cancer tissue

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 60age old
• Gender: Female

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Habu Yuji
• Secondary ID(s): UMIN000020856