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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020856

Enrollment

Registered

2016-02-04

Start date

2016-02-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial cancer

Interventions

1)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). 2)Metformin will be administered in patients who fulfill the eligibility criteria. Metfomin will be administrated in patient

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of metformin on H19 expression in endometrial cancer tissue	—

Secondary

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

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactAkira Mitsuhashi

Graduate School of Medicine, Chiba University Reproductive Medicine

antira@faculty.chbia-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026