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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Princess Margaret Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Sarah E Ferguson, MD — University Health Network, Toronto
• Study coordinator: Tara Zad
• Email: Tara.Zad@uhn.ca
• Phone: 416-946-4501

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.