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., & 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), pp. 14-21.

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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.

Impact and interest:

8 citations in Scopus
9 citations in Web of Science®
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ID Code: 78713
Item Type: Journal Article
Refereed: Yes
Keywords: Endometrial cancer, Progestin/Progesterone, Levonorgestrel intrauterine device, Metformin, Weight loss, Physical activity
DOI: 10.1016/j.cct.2014.06.014
ISSN: 1551-7144
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PUBLIC HEALTH AND HEALTH SERVICES (111700)
Divisions: Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Funding:
  • CANCER AUSTRALIA/#1044900
Copyright Owner: Crown Copyright 2014
Copyright Statement: This is the author’s version of a work that was accepted for publication in Contemporary Clinical Trials. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Contemporary Clinical Trials, Volume 39, Issue 1, (September 2014), DOI: 10.1016/j.cct.2014.06.014
Deposited On: 17 Nov 2014 23:44
Last Modified: 23 Jun 2017 07:01

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