CA Endometrium, Metformin
Conditions
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.
Interventions
Regular strength metformin (850 mg/tab)
DRUGPlacebo Oral Tablet
Starch based placebo manufatured to mimic Metformin 850 mg
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change of grade in endometrial tumor | 4 weeks | metformin administration reduced grade in endometrial tumor when given for 4 weeks before hysterectomy. |
Countries
Thailand
Outcome results
None listed