Plain English Summary
Trial website
Additional identifiers
EudraCT number
2014-000991-25
ClinicalTrials.gov number
Protocol/serial number
17351
Study information
Scientific title
Presurgical metformin for women with endometrial cancer: a randomised placebo controlled trial
Acronym
Study hypothesis
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
NRES Committee North west-Haydock, 23/09/2014, ref: 14/NW/1236
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
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 trial start date
06/02/2015
Overall trial end date
31/10/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 90; UK Sample Size: 90
Participant 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
Recruitment start date
06/02/2015
Recruitment end date
02/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Central Manchester Foundation Trust (lead site)
Manchester
M13 9WL
United Kingdom
Trial participating centre
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan, Lancashire
WN1 2NN
United Kingdom
Trial participating centre
Christie Hospital NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
Trial participating centre
Pennine Acute Hospitals NHS Trust
Manchester
M8 5RB
United Kingdom
Trial participating centre
Tameside General Hospital
Ashton-under-Lyne
OL6 9RW
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
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).
Intention to publish date
30/04/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30563932