Endometrial carcinoma or hyperplasia MedDRA version: 17.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Metformin hydrochloride
Product Name: Metformin hydrochloride
Product Code: N/A
Pharmaceutical Form: Tablet
Pharmaceutical f
Sponsors
Central Manchester University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Biopsy-proven type 1 endometrial carcinoma or severe atypical hyperplasia 2. Scheduled surgical treatment by hysterectomy n 5-35 days' time 3. Informed consent 4. Aged 18 years or more Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: 1. Current treatment with metformin 2. Diabetic on hypoglycaemic medication 3. Inability to consent due to lack of capacity or language barriers 4. Unable to comply with treatment protocol 5. Type 2 endometrial cancer 6. Severe renal impairment (Serum creatinine >130umol/L or eGFR <45ml/min/1.732m2) 7. Severe hepatic impairment (abnormal LFTs to be discussed on case by case basis with hepatologist) 8. Current alcohol abuse 9. Sensitivity/hypersensitivity to biguanides 10. Current treatment with other mTOR inhibitors or chemotherapeutic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether metformin has a biological effect on endometrial cancer.; Secondary Objective: To evaluate the biological mechanisms of metformin treatment in endometrial cancer. ;Primary end point(s): Ki-67 proliferation index (tumour analysis);Timepoint(s) of evaluation of this end point: Pre- and post- treatment with the IMP (metformin or placebo) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Physiological (blood glucose, insulin, HbA1C, adiponectin, CRP, IGF-1) Tumour (cleaved caspase3, cleaved PARP, PTEN, AMPK, phospho-AMPK, mTOR, S6) Metformin concentration in blood and urine ;Timepoint(s) of evaluation of this end point: Pre- and post- treatment with the IMP (metformin or placebo) | — |
Countries
United Kingdom
Contacts
Public ContactCMFT Research Office
Central Manchester University Hospitals NHS Foundation Trust
Outcome results
None listed