Improving the Treatment for Women With Early Stage Cancer of the Uterus (feMMe)
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|ClinicalTrials.gov Identifier: NCT01686126|
Recruitment Status : Recruiting
First Posted : September 17, 2012
Last Update Posted : August 28, 2019
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%).
|Condition or disease||Intervention/treatment||Phase|
|Complex Endometrial Hyperplasia With Atypia Grade 1 Endometrial Endometrioid Adenocarcinoma||Drug: Levonorgestrel Drug: Metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium|
|Actual Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Mirena + Metformin
Metformin tablets, 500mg twice daily orally, 6 months Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months
Other Name: Mirena
Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months
Other Name: Mirena
Experimental: Mirena + Weight Loss Intervention
Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months Weight Loss Intervention will be delivered via Weight Watchers
Other Name: Mirena
- Pathological complete response [ Time Frame: 6 months ]
- Predict the response to treatment [ Time Frame: 6 months ]To predict the response to treatment through blood and tissue molecular biomarkers and to increase our molecular understanding of the biological pathogenesis of "early" EAC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686126
|Contact: Vanessa L Taylor||+61 7 3346 firstname.lastname@example.org|
|Contact: Trudi Cattley, BSc||+61 7 3346 email@example.com|
|Study Chair:||Andreas Obermair||Queensland Centre for Gynaecological Cancer|