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

November 28, 2024 updated by: Rajavithi Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: metformin
The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy
Drug: Metformin Hydrochloride 850 MG
Regular strength metformin (850 mg/tab)
Other Names:
  • if any
Placebo Comparator: placebo
The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy
Drug: Placebo Oral Tablet
Starch based placebo manufatured to mimic Metformin 850 mg
Other Names:
  • if any

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of grade in endometrial tumor
Time Frame: 4 weeks
metformin administration reduced grade in endometrial tumor when given for 4 weeks before hysterectomy.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rjmetformin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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