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

Hawkes, A. L., Quinn, M., Gebski, V., Armes, J., Brennan, D., Janda, M., for the feMME Trial Committee and Obermair, A. (2014) 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. Contemporary Clinical Trials, 39 1: 14-21. doi:10.1016/j.cct.2014.06.014

Attached Files (Some files may be inaccessible until you login with your UQ eSpace credentials)
Name Description MIMEType Size Downloads

Author Hawkes, A. L.
Quinn, M.
Gebski, V.
Armes, J.
Brennan, D.
Janda, M.
for the feMME Trial Committee
Obermair, A.
Total Author Count Override 7
Title 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
Journal name Contemporary Clinical Trials   Check publisher's open access policy
ISSN 1559-2030
1551-7144
Publication date 2014-09
Sub-type Article (original research)
DOI 10.1016/j.cct.2014.06.014
Open Access Status
Volume 39
Issue 1
Start page 14
End page 21
Total pages 8
Place of publication Philadelphia, United States
Publisher Elsevier
Collection year 2015
Language eng
Subject 2736 Pharmacology (medical)
2700 Medicine
Formatted abstract
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.
Keyword Endometrial cancer
Levonorgestrel intrauterine device
Metformin
Physical activity
Progestin/Progesterone
Weight loss
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Mater Research Institute-UQ (MRI-UQ)
Official 2015 Collection
School of Medicine Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 6 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 7 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Wed, 07 Jan 2015, 13:13:21 EST by Ms Dulcie Stewart on behalf of Mater Research Institute-UQ