Clincosm LogoSign in Get a demo

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

Sponsor
Rajavithi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03618472
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
18.2
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Metformin Hydrochloride 850 MG
  • Drug: Placebo Oral Tablet
 N/A

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 Design

Study Type:
Interventional
Actual 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 :
Jul 1, 2018
Actual Primary Completion Date :
Nov 30, 2019
Actual Study Completion Date :
Jan 7, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of Ki-67 expression in endometrial tumor [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 [4 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rajavithi Hospital Bangkok Thailand 10400

    Sponsors and Collaborators

    • Rajavithi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rajavithi Hospital
    ClinicalTrials.gov Identifier:
    NCT03618472
    Other Study ID Numbers:
    • Rjmetformin
    First Posted:
    Aug 7, 2018
    Last Update Posted:
    Jan 9, 2020
    Last Verified:
    Oct 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Metformin

    Study Results

    No Results Posted as of Jan 9, 2020