Condition category
Cancer
Date applied
04/03/2015
Date assigned
05/03/2015
Last edited
12/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Miss Suzanne Rowland

ORCID ID

Contact details

Christie Hospital NHS Foundation Trust
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

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.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=17351

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 measures

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

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

31/10/2017

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

Sponsor information

Organisation

Central Manchester University Hospitals NHS Trust (CMFT)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/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. 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.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes