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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jul 3, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of bariatric surgery (a type of weight loss surgery) combined with progestin therapy (a hormone treatment) for young women who have obesity and are diagnosed with early-stage endometrial cancer or atypical hyperplasia, which is a pre-cancer condition. The goal is to see if losing significant weight through surgery can help these women respond better to treatment and preserve their ability to have children. Currently, many women with these conditions do not have good treatment options that also consider their desire to maintain fertility.

To be eligible for the trial, participants must be women aged between 18 and 45 with a body mass index (BMI) of 35 or higher, meaning they are considered obese. They should have a specific type of early-stage endometrial cancer or atypical hyperplasia and want to preserve their fertility. Participants will undergo bariatric surgery and receive progestin therapy, and they will be closely monitored throughout the process. It’s important to note that certain health conditions and previous surgeries may disqualify some individuals from participating in the trial. This study is currently recruiting participants, so if you or someone you know fits the criteria, it could be an opportunity to explore new treatment options.

Gender

FEMALE

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