Endometrial CancerAtypical HyperplasiaBariatric Surgery Candidate
Investigational drug(s) / intervention(s)
Bariatric Surgery
Bariatric Surgery: 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.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
41 Years
Healthy volunteers
No
Inclusion Criteria:
* BMI ≥ 35
* Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
* Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by imaging performed (MRI, CT)
* ECOG status \<2
* Desire for fertility preservation
* No contraindications to progestin intrauterine device (IUD)
* Have signed an approved informed consent form
Exclusion Criteria:
* Evidence of myometrial invasion or extra-uterine disease on imaging
* High grade or p53 endometrial cancer
* History of other malignancies, except if curatively treated with no evidence of disease for \> 5 years
* Previous major upper abdominal surgery (ex. previous bariatric surgery, splenectomy, partial gastrectomy, liver resection, bowel resection). Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion.
* Current use of weight loss medication. NB: patients taking glucagon-like peptide 1 (GLP-1) agonists (e.g., OZEMPIC) for the treatment of diabetes will not be excluded.
* Contraindications to sleeve gastrectomy
* Medical co-morbidity with end-organ dysfunction
* Unable to understand and participate in the informed consent process
* Currently pregnant
* Active smoking in ≤6 months
* Active substance use disorder
* Current untreated or severe psychiatric issue
Primary outcome measure(s)
Recruitment Rate — Year 5 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.
Trial sites (1)
Facility
City
Region
Status
Princess Margaret Hospital
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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