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Completed

NCT Number: NCT03618472

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

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.

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Key information

Conditions

Metformin CA Endometrium

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin Hydrochloride 850 MG

Drug

Regular strength metformin (850 mg/tab)

Other names: if any

Placebo oral tablet

Drug

Starch based placebo manufatured to mimic Metformin 850 mg

Other names: if any

Primary outcomes

  1. Change of Ki-67 expression in endometrial tumor

    Time frame: 4 weeks

    metformin administration reduced Ki-67 expression in endometrial tumor when given for 4 weeks before hysterectomy.

Secondary outcomes

  1. Change of grade in endometrial tumor

    Time frame: 4 weeks

    metformin administration reduced grade in endometrial tumor when given for 4 weeks before hysterectomy.

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 7, 2018
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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