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

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ClinicalTrials.gov Identifier: NCT03618472
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

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.

Condition or disease Intervention/treatment Phase
Metformin CA Endometrium Drug: Metformin Hydrochloride 850 MG Drug: Placebo Oral Tablet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells : A Randomized Double Blind Placebo-controlled Trial
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

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 Name: 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 Name: if any




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618472


Locations
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Thailand
Rajavithi Hospital Recruiting
Bangkok, Thailand, 10400
Contact: charuwan manmee, Phd    023548108 ext 2803    charuwan_manmee@yahoo.com   
Principal Investigator: kittisak Petchsila, MD         
Sponsors and Collaborators
Rajavithi Hospital

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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT03618472     History of Changes
Other Study ID Numbers: Rjmetformin
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Metformin
Uterine Diseases
Genital Diseases, Female
Hypoglycemic Agents
Physiological Effects of Drugs