Brief Title
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Official Title
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Brief Summary
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.
Detailed Description
The incidence of endometrial cancer is increasing at an alarming rate (2.6% per year). This
trend parallels the rising rate of obesity, the most significant increasing risk factor for
endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia
who want to maintain their fertility and thus avoid hysterectomy are treated with progestin
therapy, such as progestin intra-uterine device (pIUD). However, the pIUD achieves cancer
regression in only 50-70% of women, and over 50% of initial responders will develop
recurrence within two years. The effectiveness of the pIUD may be improved if the driver of
endometrial cancer (obesity) was simultaneously addressed. Multiple epidemiologic studies
have demonstrated that bariatric surgery reduces the risk of developing endometrial cancer.
Our research aims to answer the question: "Is bariatric surgery in addition to the pIUD a
feasible and acceptable option for young women with endometrial cancer/atypical hyperplasia
who wish to maintain their childbearing potential compared to standard treatment of pIUD
alone?
This is a pilot randomized controlled trial to assess the feasibility of a full-scale
randomized controlled trial. Eligible women will be identified and consented over a 21-month
period, and participants will be randomized to bariatric surgery plus standard pIUD
(intervention group) or to standard pIUD alone (non-intervention group) in a 1:1 fashion.
Study Type
Interventional
Primary Outcome
Recruitment Rate
Secondary Outcome
Completion of Bariatric Surgery
Condition
Endometrial Cancer
Intervention
Bariatric Surgery
Study Arms / Comparison Groups
Bariatric Surgery and Progestin Intrauterine Device
Description: This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
36
Start Date
August 1, 2020
Completion Date
August 1, 2023
Primary Completion Date
August 1, 2023
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
physical exam or 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
- Evidence of adenomyosis seen on MRI
- Previous major upper abdominal surgery (ex. 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
- Contraindications to sleeve gastrectomy
- Medical co-morbidity with end-organ dysfunction
- Unable to understand and participate in the informed consent process
- Currently pregnant
Gender
Female
Ages
18 Years - 41 Years
Accepts Healthy Volunteers
No
Contacts
Sarah E Ferguson, MD, 416-946-4501, [email protected]
Administrative Informations
NCT ID
NCT04008563
Organization ID
19-5487
Responsible Party
Sponsor
Study Sponsor
University Health Network, Toronto
Study Sponsor
Sarah E Ferguson, MD, Principal Investigator, University Health Network, Toronto
Verification Date
March 2020