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

Primary Purpose

Metformin, CA Endometrium

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Metformin Hydrochloride 850 MG

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Metformin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

metformin

placebo

Arm Description

The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy

The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy

Outcomes

Primary Outcome Measures

Change of Ki-67 expression in endometrial tumor

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

Secondary Outcome Measures

Change of grade in endometrial tumor

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

Full Information

NCT ID

NCT03618472

First Posted

August 1, 2018

Last Updated

January 7, 2020

Sponsor

Rajavithi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03618472

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

November 30, 2019 (Actual)

Study Completion Date

January 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metformin, CA Endometrium

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

metformin

Arm Type

Experimental

Arm Description

The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy

Intervention Type

Drug

Intervention Name(s)

Metformin Hydrochloride 850 MG

Other Intervention Name(s)

if any

Intervention Description

Regular strength metformin (850 mg/tab)

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Other Intervention Name(s)

if any

Intervention Description

Starch based placebo manufatured to mimic Metformin 850 mg

Primary Outcome Measure Information:

Title

Change of Ki-67 expression in endometrial tumor

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change of grade in endometrial tumor

Description

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

Time Frame

4 weeks

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Rajavithi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

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

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