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

NCT ID: NCT03618472

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-01-30

Brief Summary

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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

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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.

Conditions

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Metformin CA Endometrium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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metformin

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

Group Type EXPERIMENTAL

Metformin Hydrochloride 850 MG

Intervention Type DRUG

Regular strength metformin (850 mg/tab)

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Starch based placebo manufatured to mimic Metformin 850 mg

Interventions

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Metformin Hydrochloride 850 MG

Regular strength metformin (850 mg/tab)

Intervention Type DRUG

Placebo Oral Tablet

Starch based placebo manufatured to mimic Metformin 850 mg

Intervention Type DRUG

Other Intervention Names

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if any if any

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rajavithi Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Rjmetformin

Identifier Type: -

Identifier Source: org_study_id