Metformin for endometrial cancer RCT
Research type
Research Study
Full title
Pre-surgical metformin for women with endometrial cancer: a randomised placebo controlled trial
IRAS ID
155883
Contact name
Emma J Crosbie
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Eudract number
2014-000991-25
Research summary
Endometrial cancer, or cancer of the lining of the womb, has become the most common cancer of the reproductive tract in British women. Obese women are at increased risk of the disease and are also more likely to die from it. The recent obesity epidemic means that more women than ever before are developing the disease. Endometrial cancer can usually be cured by surgery but for obese or elderly women, surgery may be dangerous. It also renders a woman infertile. There is an urgent need to develop non-surgical treatments and preventative strategies for an increasingly obese female population.
Metformin is one of the drugs used to treat diabetes. Recently, its role in the treatment of cancer has been explored. Diabetics who take metformin for many years are less likely to develop and die from cancer than those who do not. They are also more likely to respond well to chemotherapy if cancer does develop. Metformin has been shown to slow down the growth of breast, prostate, colon and endometrial cancers in the laboratory. We conducted a small feasibility trial of pre-surgical metformin in newly diagnosed patients with atypical endometrial hyperplasia or endometrial cancer. Recruitment targets were met, metformin was well tolerated and the study design was acceptable to patients.
This study will test the effects of metformin on cellular proliferation in endometrial cancer and its pre-malignant condition, severe atypical hyperplasia. Women with endometrial cancer or severe atypical hyperplasia will receive metformin or placebo for one to five weeks while they wait for their surgery. The effects of metformin will then be assessed by comparing the characteristics of the endometrial biopsy taken at diagnosis with those of an endometrial biopsy taken at hysterectomy.
REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/1236
Date of REC Opinion
23 Sep 2014
REC opinion
Further Information Favourable Opinion