An interventional study of Bariatric Surgery in Endometrial Cancer, Atypical Hyperplasia and Bariatric Surgery Candidate, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.
The incidence of endometrial cancer is increasing at an alarming rate (2.6% per year). This trend parallels the rising rate of obesity, the most significant increasing risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility and thus avoid hysterectomy are treated with progestin therapy, such as progestin intra-uterine device (pIUD). However, the pIUD achieves cancer regression in only 50-70% of women, and over 50% of initial responders will develop recurrence within two years. The effectiveness of the pIUD may be improved if the driver of endometrial cancer (obesity) was simultaneously addressed. Multiple epidemiologic studies have demonstrated that bariatric surgery reduces the risk of developing endometrial cancer. Our research aims to answer the question: "Is bariatric surgery in addition to the pIUD a feasible and acceptable option for young women with endometrial cancer/atypical hyperplasia who wish to maintain their childbearing potential compared to standard treatment of pIUD alone?
This is a pilot randomized controlled trial to assess the feasibility of a full-scale randomized controlled trial. Eligible women will be identified and consented over a 21-month period, and participants will be randomized to bariatric surgery plus standard pIUD (intervention group) or to standard pIUD alone (non-intervention group) in a 1:1 fashion.
Exclusion Criteria:
This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
Procedure: Bariatric Surgery
This group will receive a progestin intrauterine device alone.
Patients who are randomized to the intervention group will receive a progestin intrauterine device and be referred for bariatric service to undergo bariatric surgery within 3 months of their study consent.
Recruitment Rate
To determine the proportion of eligible women who agree to participate in the study (recruitment rate). The primary outcome will be met and a full scale randomized controlled trial to assess efficacy will be conducted if ≥ 40% recruitment rate is achieved. Patients' reasons for participation or non-participation will be recorded.
Time frame: Year 5
Completion of Bariatric Surgery
Proportion of patients who complete bariatric surgery within 3-4 months (-2/+ 4 weeks) of randomization. A rate of \>85% will be considered feasible.
Time frame: Year 5
Loss to Follow-Up Rate
Loss to follow-up rate, defined as proportion of patients who do not complete 15-month assessment. A loss to follow-up rate of \<20% will be considered feasible.
Time frame: Year 6
Completion of Patient Reported Outcome Questionnaires
Completion rate of patient reported outcomes that will be used in the full-scale randomized controlled trial. Completion of \>80% of patient reported outcomes at baseline will indicate that use of these questionnaires is feasible.
Time frame: Year 5
Complete Response Rate
Overall complete response rate (CRR) after treatment with progestin intrauterine device (pIUD). This study is not powered to detect an improvement in CRR in the intervention vs. non-intervention group. However, the proportion of women who obtain a complete response in the pIUD alone group at 15 months will be used as the baseline CRR for this population and will be used to derive a sample size for a full-scale randomized controlled trial. We believe that this will be more accurate than using published data retrospective studies that are not specific to women with obesity. We will also collect the following data: (a) time to complete response, (b) overall recurrence rate, and (c) time to recurrence.
Time frame: Year 6
Plan to share: No
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University Health Network, Toronto