Interventions for weight reduction in obesity to improve survival in women with endometrial cancer.
Heather Agnew, Sarah Kitson, Emma J Crosbie
https://pubmed.ncbi.nlm.nih.gov/36971688Actively Recruiting
Phase Not Applicable
Age: 18Years - 41Years
FEMALE
ID04008563
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Led by University Health Network, Toronto · Updated on 2025-03-14
36
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Young women with obesity are increasingly developing atypical hyperplasia (a pre-cancer condition) and endometrial cancer. Progestin therapy, such as a progestin intrauterine device (pIUD), is the standard treatment for those wishing to preserve fertility, but it does not address obesity, the main driver of these conditions. This trial aims to explore whether combining bariatric surgery with pIUD therapy can improve treatment response and reduce recurrence rates compared to pIUD alone. Participants are randomly assigned to one of two groups: one group will receive the standard pIUD treatment plus bariatric surgery within three months of consent, while the other group will receive the pIUD treatment alone. This pilot randomized controlled trial will assess the feasibility of a larger study by monitoring recruitment, surgery completion, and patient outcomes over several years. During the study, women will be closely monitored with imaging to ensure no spread beyond the uterus and assessed for treatment response and quality of life through patient questionnaires. Researchers will track recruitment rates, surgery completion, follow-up rates, and cancer response. The study lasts several years, with key milestones at years five and six, to gather comprehensive data on treatment feasibility and effectiveness.
CONDITIONS
Brief Title
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Who Can Participate
Age: 18Years - 41Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) of 35 or higher
- Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
- Clinical stage 1 disease with no evidence of spread beyond the uterus by imaging
- Eastern Cooperative Oncology Group (ECOG) status less than 2
- Desire to preserve fertility
- No contraindications to progestin intrauterine device (IUD)
- Signed informed consent form
You will not qualify if you...
- Evidence of myometrial invasion or disease beyond the uterus on imaging
- High grade or p53 endometrial cancer
- History of other cancers unless cured with no disease for over 5 years
- Previous major upper abdominal surgery such as bariatric surgery, splenectomy, gastrectomy, liver or bowel resection
- Current use of weight loss medication (except GLP-1 agonists for diabetes)
- Contraindications to sleeve gastrectomy
- Medical conditions with end-organ dysfunction
- Unable to understand or participate in informed consent
- Currently pregnant
- Active smoking within past 6 months
- Active substance use disorder
- Untreated or severe psychiatric issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 5 years
Participants receive a progestin intrauterine device (pIUD). Those randomized to the intervention group will also undergo bariatric surgery within 3 months of consent.
Initial placement of pIUD and surgery within 3 months; follow-up visits as scheduled by clinical care
Follow-up
Duration - Up to 6 years
Participants are monitored for treatment response, recurrence, and completion of patient-reported outcome questionnaires.
Periodic visits for assessment and questionnaires
Trial Site Locations
Total: 1 location
1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
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Research Team
T
Tara Zad
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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