Comparison of the Effectiveness Metformin for Deceasing P... | NCT03618472

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

NCT03618472

Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Status

Completed

Last Update Posted

Dec 3, 2024Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Metformin
CA Endometrium

Interventions

Metformin Hydrochloride 850 MG
Placebo Oral Tablet

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Nov 30, 2019Actual

Completion Date

Jan 30, 2020Actual

First Submitted Date

Aug 1, 2018

First Submission Date that Met QC Criteria

Aug 6, 2018

First Posted Date

Aug 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2024

Last Update Posted Date

Dec 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metformin	Experimental	The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy	Drug: Metformin Hydrochloride 850 MG
placebo	Placebo Comparator	The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy	Drug: Placebo Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin Hydrochloride 850 MG	Drug	Regular strength metformin (850 mg/tab)	metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Ki-67 expression in endometrial tumor	metformin administration reduced Ki-67 expression in endometrial tumor when given for 4 weeks before hysterectomy.	4 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rajavithi Hospital		Bangkok	Bangkok	10400	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided