Comparison of the Effectiveness Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells

Not Applicable

Completed

• Conditions: Metformin; CA Endometrium
• Interventions: Drug: Metformin Hydrochloride 850 MG; Drug: Placebo Oral Tablet

• Registration Number: NCT03618472
• Lead Sponsor: Rajavithi Hospital

Brief Summary

Comparison of the effectiveness metformin versus placebo for deceasing proliferative marker Ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells.

Detailed Description

Endometrial cancer is one of the most common gynecological cancers. Preclinical studies in endometrial cancer (EC) show that metformin reduces cellular proliferation by PI3K-AKT-mTOR inhibition. The investigators tested the hypothesis that short-term presurgical metformin reduces cellular proliferation in endometrial cancer. However, no good quality of evidence base supports the effectiveness of metformin for deceasing proliferative marker in endometrial cancer.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-07
• Status Verified: 2018-10
• Primary Completion: 2019-11-30
• Study Completion: 2020-01-30
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Women with endometrial cancer who undergoing complete surgical staging and agrees to participate in this study

Exclusion Criteria

• Women without diabetes type 1 and 2
• Women who have allergy Biguanide
• Women who have hypoglycemic medication
• Women who have GFR <45 ml/min/1.73 m2
• Women who have evidence of stage 3 or 4 of endometrial cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin	Metformin Hydrochloride 850 MG	The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy
placebo	Placebo Oral Tablet	The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy

Primary Outcome Measures

Name	Time	Method
Change of Ki-67 expression in endometrial tumor	4 weeks	metformin administration reduced Ki-67 expression in endometrial tumor when given for 4 weeks before hysterectomy.

Secondary Outcome Measures

Name	Time	Method
Change of grade in endometrial tumor	4 weeks	metformin administration reduced grade in endometrial tumor when given for 4 weeks before hysterectomy.

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand