Weight-loss surgery with hormone treatment for early womb lining cancer in young women
Tests bariatric surgery plus progestin therapy in women with obesity and early endometrial disease.
Plain-language title generated from the registry record
Registry title: Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Key facts
- Where
- Toronto, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 41 years old?
Source: NCT04008563, who can take part
Where in Canada
- Princess Margaret HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT04008563
- Record updated
- 14 March 2025
- Original description
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.Read full original descriptionShow less
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
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.
Inclusion: 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: 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; Evidence of myometrial invasion or extra-uterine disease on imaging; High grade or p53 endometrial cancer; 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; Active substance use disorder; Current untreated or severe psychiatric issue; History of other malignancies, except if curatively treated with no evidence of disease for > 5 years; 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.