PREMIUM (PRE-Surgical Metformin In Uterine Malignancies) study
- Conditions
- CancerTopic: CancerSubtopic: Gynaecological CancerDisease: Uterus/Endometrium
- Registration Number
- ISRCTN88589234
- Lead Sponsor
- Central Manchester University Hospitals NHS Trust (CMFT)
- Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30563932
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
1. Biopsy-proven type 1 endometrial carcinoma or severe atypical endometrial hyperplasia
2. Scheduled surgical treatment by hysterectomy in 5-35 days’ time
3. Informed consent
4. Age 18 years or more
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tumour analysis - Ki-67; Timepoint(s): screening and pre operative
- Secondary Outcome Measures
Name Time Method <br> 1. Physiological analyses - insulin resistance and obesity markers; Timepoint(s): Screening and pre operative<br> 2. Tolerability of treatment; Timepoint(s): pre operative<br> 3. Tumour analysis - Apoptotic markers; Timepoint(s): screening and pre operative<br> 4. Tumour analysis - PI3K-Akt-mTOR signal transduction pathway molecules; Timepoint(s): screening and pre operative<br>