PROTEC1
Research type
Research Study
Full title
PROgesterone Therapy for Endometrial Cancer prevention in obese women (PROTEC)
IRAS ID
167081
Contact name
Emma Crosbie
Contact email
Sponsor organisation
Central Manchester University Hospitals NHS Foundation Trust
Eudract number
2014-005610-37
Duration of Study in the UK
2 years, 4 months, 0 days
Research summary
Endometrial cancer, or womb cancer, 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. Womb 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 preventative strategies for an increasingly obese female population.
The Mirena IUS is a T-shaped plastic device which releases a hormone called levonorgestrel, which is a type of progesterone. It is currently licensed for contraception, treatment of heavy periods and the prevention of womb cancer in women taking HRT. The Mirena IUS is usually inserted in GP surgeries or sexual health and gynaecology clinics and has been used extensively in the general female population.
Clinical trials are underway looking at its use for treating pre-cancer and cancer where surgery is not possible and for preventing womb cancer in patients with genetic risk factors. Because of the high risk of developing womb pre-cancer or cancer with obesity this trial aims to study how the Mirena IUS changes the molecular markers that are thought to be related to the development of cancer. We also wish to assess whether the Mirena IUS is acceptable to obese women for womb protection and whether it has any impact on hormone levels throughout the body.
Women with a BMI >40 who are seen by the Sleep Apnoea Service at Salford Royal Hospital will be asked if they wish to participate in the trial. They will complete a questionnaire, blood samples and biopsies of the lining of the womb taken before and after insertion of a Mirena IUS.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
15/EE/0063
Date of REC Opinion
2 Apr 2015
REC opinion
Further Information Favourable Opinion