Improving the Treatment for Women With Early Stage Cancer of the Uterus
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Currently the standard treatment for early stage endometrial cancer or endometrial
hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and
removal of both ovaries. While highly effective, this surgery carries significant side
effects for:
- young women who still wish to have children and would lose fertility; and
- women with one or more disorders (or diseases) in addition to the early stage
endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are
at risk for surgical complications making surgery unsafe.
This study will access a new approach to the treatment of endometrial cancer to spare women
of having to undergo major surgery that may be unwanted or unnecessary.
Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent
thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement
therapy (HRT). However it is not approved to treat early stage endometrial cancer or
endometrial hyperplasia with atypia. This research project will test to see if Mirena is an
effective treatment for early stage endometrial cancer and endometrial hyperplasia with
atypia.
Metformin is approved in Australia to treat Diabetes. However it is not approved to treat
early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an
experimental treatment for early stage endometrial cancer and endometrial hyperplasia with
atypia. This means that it must be tested to see if it is an effective treatment for early
stage endometrial cancer and endometrial hyperplasia with atypia.
Weight loss interventions are feasible and safe, and already being implemented by
gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight
induces a large biological effect (for example reduces incidence of diabetes by 58%, and
hypertension by 26%).
Phase:
Phase 2
Details
Lead Sponsor:
Queensland Centre for Gynaecological Cancer
Collaborators:
Queensland University of Technology The University of Queensland