Type 1 or endometrioid adenocarcinoma of the endometrium Cancer Malignant neoplasm of endometrium
Conditions
Interventions
Current interventions as of 06/09/2013:
Metformin Group
Participants in the Metformin group will receive 850 mg metformin hydrochloride twice daily by mouth for one to
Sponsors
Central Manchester University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 06/09/2013: 1. Biopsy-proven atypical endometrial hyperplasia or type 1 endometrial carcinoma 2. Scheduled for surgical treatment in 1 or more weeks? time 3. Written informed consent to participate in the trial 4. Females aged 18 years or older Previous inclusion criteria: 1. Biopsy-proven type 1 endometrial carcinoma 2. Scheduled for surgical treatment in 2 or more weeks? time 3. Written informed consent to participate in the trial 4. Females aged 18 years or older
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 06/09/2013: 1. Already receiving metformin treatment 2. Type 1 or 2 diabetes mellitus on drug treatment 3. Renal or hepatic impairment 4. Unable to comply with treatment protocol Previous exclusion criteria: 1. Already receiving metformin treatment 2. Type 1 or 2 diabetes mellitus 3. Renal or hepatic impairment 4. Unable to comply with treatment protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Test for Ki-67 | — |
Secondary
| Measure | Time frame |
|---|---|
| Test for: 1. Phospho-H3 2. Cleaved caspase-3 and cleaved PARP 3. AKT, phosphorylated AKT 4. ERK1,2, phosphorylated ERK 1,2 5. PTEN, strathmin 6. Phosphorylation status of key signal transduction molecules (mTOR pathway) 7. Insulin receptor/phosphorylated insulin receptor 8. Fasting serum glucose, insulin, IGFBP-1 and C-peptide levels 9. Tolerability of metformin treatment | — |
Countries
United Kingdom
Outcome results
None listed