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

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-metformin-before-surgery-for-womb-cancer

Contact information

Mr Richard Hutson
Public

Manchester Academic Health Science Centre
The Christie NHS Foundation Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a patient information sheet
Scientific titlePresurgical metformin for women with endometrial cancer: a randomised placebo controlled trial
Study objectivesRandomised 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) studiedTopic: Cancer; Subtopic: Gynaecological Cancer; Disease: Uterus/Endometrium
InterventionMetformin 850mg or placebo given once daily for 3 days and then twice a day until surgery
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Metformin
Primary outcome measureTumour analysis - Ki-67; Timepoint(s): screening and pre operative
Secondary outcome measures1. 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 date06/02/2015
Completion date31/10/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 90; UK Sample Size: 90
Key inclusion criteria1. 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 criteria1. 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 enrolment06/02/2015
Date of final enrolment02/03/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Central Manchester Foundation Trust (lead site)
Manchester
M13 9WL
United Kingdom
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan, Lancashire
WN1 2NN
United Kingdom
Christie Hospital NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
Pennine Acute Hospitals NHS Trust
Manchester
M8 5RB
United Kingdom
Tameside General Hospital
Ashton-under-Lyne
OL6 9RW
United Kingdom

Sponsor information

Central Manchester University Hospitals NHS Trust (CMFT)
Hospital/treatment centre

Genetic Medicine, Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom

ROR logo "ROR" https://ror.org/00he80998

Funders

Funder type

Government

National Institute for Health Research
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 date30/04/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planUpon 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 planThe 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.