Improving treatment for obese women with early stage cancer of the uterus:
rationale and design of the levonorgestrel intrauterine device ± metformin ±
weight loss in endometrial cancer (feMME) trial.
Author(s): Hawkes AL(1), Quinn M(2), Gebski V(3), Armes J(4), Brennan D(5), Janda M(1);
feMME Trial Committee, Obermair A(6).
Affiliation(s): Author information:
(1)School of Public Health and Social Work, Institute for Health and Biomedical
Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.
(2)Royal Women's Hospital Royal Women's Hospital, Melbourne, Victoria, Australia.
(3)National Health and Medical Research Council Clinical Trials Centre, Sydney,
New South Wales, Australia. (4)Pathology, Mater Adult Hospital, South Brisbane,
Queensland, Australia. (5)Queensland Centre for Gynaecological Cancer, Royal
Brisbane and Women's Hospital, Brisbane, Queensland, Australia. (6)School of
Public Health and Social Work, Institute for Health and Biomedical Innovation,
Queensland University of Technology, Brisbane, Queensland, Australia; Queensland
Centre for Gynaecological Cancer, Royal Brisbane and Women's Hospital, Brisbane,
Queensland, Australia.
Publication date & source: 2014, Contemp Clin Trials. , 39(1):14-21
PURPOSE: Endometrial adenocarcinoma (EC) is the most common gynaecologic cancer.
Up to 90% of EC patients are obese which poses a health threat to patients
post-treatment. Standard treatment for EC includes hysterectomy, although this
has significant side effects for obese women at high risk of surgical
complications and for women of childbearing age. This trial investigates the
effectiveness of non-surgical or conservative treatment options for obese women
with early stage EC. The primary aim is to determine the efficacy of:
levonorgestrel intrauterine device (LNG-IUD); with or without metformin (an
antidiabetic drug); and with or without a weight loss intervention to achieve a
pathological complete response (pCR) in EC at six months from study treatment
initiation. The secondary aim is to enhance understanding of the molecular
processes and to predict a treatment response by investigating EC biomarkers.
METHODS: An open label, three-armed, randomised, phase-II, multi-centre trial of
LNG-IUD ± metformin ± weight loss intervention. 165 participants from 28 centres
are randomly assigned in a 3:3:5 ratio to the treatment arms. Clinical, quality
of life and health behavioural data will be collected at baseline, six weeks,
three and six months. EC biomarkers will be assessed at baseline, three and six
months.
CONCLUSIONS: There is limited prospective evidence for conservative treatment for
EC. Trial results could benefit patients and reduce health system costs through a
reduction in hospitalisations and through lower incidence of adverse events
currently observed with standard treatment.
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