PREMIUM (PRE-Surgical Metformin In Uterine Malignancies) study
| ISRCTN | ISRCTN88589234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88589234 |
| EudraCT/CTIS number | 2014-000991-25 |
| Secondary identifying numbers | 17351 |
- Submission date
- 04/03/2015
- Registration date
- 05/03/2015
- Last edited
- 18/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Mr Richard Hutson
Public
Public
Manchester Academic Health Science Centre
The Christie NHS Foundation Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Presurgical metformin for women with endometrial cancer: a randomised placebo controlled trial |
| Study objectives | Randomised placebo-controlled trial looking to determine whether metformin inhibits cellular growth in endometrial cancer and severe atypical endometrial hyperplasia. It will also look at the biological effects of metformin in endometrial cancer and hyperplasia. |
| Ethics approval(s) | NRES Committee North west-Haydock, 23/09/2014, ref: 14/NW/1236 |
| Health condition(s) or problem(s) studied | Topic: Cancer; Subtopic: Gynaecological Cancer; Disease: Uterus/Endometrium |
| Intervention | Metformin 850mg or placebo given once daily for 3 days and then twice a day until surgery |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure | Tumour analysis - Ki-67; Timepoint(s): screening and pre operative |
| Secondary outcome measures | 1. Physiological analyses - insulin resistance and obesity markers; Timepoint(s): Screening and pre operative 2. Tolerability of treatment; Timepoint(s): pre operative 3. Tumour analysis - Apoptotic markers; Timepoint(s): screening and pre operative 4. Tumour analysis - PI3K-Akt-mTOR signal transduction pathway molecules; Timepoint(s): screening and pre operative |
| Overall study start date | 06/02/2015 |
| Completion date | 31/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 90; UK Sample Size: 90 |
| Key inclusion criteria | 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 |
| Key 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 |
| Date of first enrolment | 06/02/2015 |
| Date of final enrolment | 02/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Central Manchester Foundation Trust (lead site)
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan, Lancashire
WN1 2NN
United Kingdom
WN1 2NN
United Kingdom
Christie Hospital NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Pennine Acute Hospitals NHS Trust
Manchester
M8 5RB
United Kingdom
M8 5RB
United Kingdom
Tameside General Hospital
Ashton-under-Lyne
OL6 9RW
United Kingdom
OL6 9RW
United Kingdom
Sponsor information
Central Manchester University Hospitals NHS Trust (CMFT)
Hospital/treatment centre
Hospital/treatment centre
Genetic Medicine, Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Upon completion the study will be published in peer reviewed, open access journals in order to increase the dissemination of the results generated. It will also form the basis for a thesis to be put forward for the award of a PhD at the University of Manchester and will be available to be viewed in this format. The results of the study will also be presented at national and international meetings to inform both clinicians and scientists with an interest in endometrial cancer. An abstract submission is being prepared for presentation at the European Gynaecological Oncology Congress in November 2017, submission to journals is likely to be in early 2018. Patients recruited to the study will be informed of the trial results and public engagement events will be undertaken to increase awareness of the study’s findings within the lay population. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Lynne Webster (lynne.webster@cmft.nhs.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/04/2019 | Yes | No | |
| Plain English results | 18/07/2019 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
18/07/2019: Link to results added to results (plain English).
29/01/2019: Publication reference added.
04/04/2017: The recruitment end date was changed from 31/10/2017 to 02/03/2017.
