Bariatric surgery combined with progestin therapy for young women with endometrial cancer

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

This study is testing if combining weight loss surgery with hormone treatment can help young women with early-stage endometrial cancer keep their fertility and improve their treatment outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 41 Years
• Sex: Female
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT04008563 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the feasibility of combining bariatric surgery with progestin therapy for young women diagnosed with atypical hyperplasia or grade 1 endometrial cancer who wish to preserve their fertility. The study aims to determine if significant weight loss from bariatric surgery can improve the effectiveness of progestin therapy, which traditionally has low response and high recurrence rates. Participants will be randomly assigned to receive either bariatric surgery plus progestin therapy or progestin therapy alone, allowing researchers to assess the potential benefits of this combined approach over a 21-month period.

Who should consider this trial

Good fit: Ideal candidates are young women with a BMI of 35 or higher, diagnosed with grade 1 endometrial cancer or atypical hyperplasia, and desiring to maintain their fertility.

Not a fit: Patients with evidence of myometrial invasion, high-grade cancer, or those who have had previous major abdominal surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved cancer regression rates and better fertility preservation for young women facing endometrial cancer.

How similar studies have performed: While the combination of bariatric surgery and progestin therapy is a novel approach, previous studies have shown that bariatric surgery can reduce the risk of developing endometrial cancer.

Eligibility criteria

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

Where this trial is running

Toronto, Ontario

• Princess Margaret Hospital — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Sarah E Ferguson, MD — University Health Network, Toronto
• Study coordinator: Tara Zad

Conditions Endometrial Cancer; Atypical Hyperplasia; Bariatric Surgery Candidate