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

Metformin Clinical Trial

Official title:

Effect of Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells : A Randomized Double Blind Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618472
• Other study ID #: Rjmetformin
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: January 7, 2020

Study information

• Verified date: October 2018
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 7, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• CA Endometrium
• Endometrial Neoplasms
• Metformin

Intervention

Drug:
• Metformin Hydrochloride 850 MG
Regular strength metformin (850 mg/tab)
• Placebo Oral Tablet
Starch based placebo manufatured to mimic Metformin 850 mg

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Ki-67 expression in endometrial tumor	metformin administration reduced Ki-67 expression in endometrial tumor when given for 4 weeks before hysterectomy.	4 weeks
Secondary	Change of grade in endometrial tumor	metformin administration reduced grade in endometrial tumor when given for 4 weeks before hysterectomy.	4 weeks