RecruitingNot ApplicableNCT04008563

Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium

Sponsor

University Health Network, Toronto

Enrollment

36 participants

Start Date

May 14, 2021

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Atypical Hyperplasia Bariatric Surgery Candidate

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: FEMALEMin Age: 18 YearsMax Age: 41 Years

Inclusion Criteria7

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 Criteria12

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

Interventions

PROCEDUREBariatric 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.