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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 30, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: metformin
    • The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy
  • Placebo Comparator: placebo
    • The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rajavithi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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