Bariatric Surgery for Endometrial Cancer
(B-FiERCE Trial)
Recruiting in Palo Alto (17 mi)
Overseen bySarah E Ferguson, MD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Must be taking: Progestin
Must not be taking: Weight loss medication
Disqualifiers: Myometrial invasion, High grade cancer, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using weight loss medication.
What data supports the effectiveness of bariatric surgery as a treatment for endometrial cancer?
Bariatric surgery can help patients with extreme obesity lose weight rapidly, making them eligible for further cancer treatments like surgery. Studies suggest that bariatric surgery reduces the risk of developing endometrial cancer and can improve outcomes when combined with other treatments.
12345Is bariatric surgery generally safe for humans?
Bariatric surgery, including procedures like the duodenal switch, is generally effective for weight loss but can have risks such as vitamin deficiencies, bleeding, and nutritional issues. It's important to have regular follow-ups and nutritional supplements to manage these risks.
678910How does bariatric surgery differ from other treatments for endometrial cancer?
Bariatric surgery is unique for endometrial cancer treatment because it helps patients lose significant weight, making them eligible for further cancer treatments like surgery. This approach is particularly beneficial for patients with extreme obesity, where traditional weight loss methods have failed, and it may also reduce the overall risk of developing endometrial cancer.
12345Eligibility Criteria
This trial is for young women with obesity who have early-stage endometrial cancer or atypical hyperplasia, want to preserve their fertility, and have a BMI ≥ 35. They should not be pregnant, have no history of certain cancers or major upper abdominal surgery (except some procedures like appendectomy), and must understand the consent process.Inclusion Criteria
Your body mass index (BMI) is 35 or higher.
I can do all my daily activities without help.
My cancer is in stage 1 and has not spread beyond the uterus.
+4 more
Exclusion Criteria
My cancer has spread beyond the uterus, as shown by scans.
I had cancer before, but it was cured and I've been cancer-free for over 5 years.
I have a health condition that affects how my organs work.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
21 months
Treatment
Participants are randomized to receive either bariatric surgery plus progestin intrauterine device or progestin intrauterine device alone
15 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of complete response rate and recurrence
6 years
Completion of Bariatric Surgery
Proportion of patients who complete bariatric surgery within 3-4 months of randomization
3-4 months
Participant Groups
The study tests if bariatric surgery combined with progestin therapy can help achieve significant weight loss and improve treatment response in obese women with early-stage endometrial cancer/atypical hyperplasia wishing to maintain fertility.
2Treatment groups
Experimental Treatment
Active Control
Group I: Bariatric Surgery and Progestin Intrauterine DeviceExperimental Treatment1 Intervention
This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
Group II: Progestin Intrauterine Device AloneActive Control1 Intervention
This group will receive a progestin intrauterine device alone.
Bariatric Surgery is already approved in European Union, United States, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Bariatric Surgery for:
- Severe obesity (BMI ≥35 kg/m2) with comorbidities
- Type 2 diabetes
- Hypertension
- Sleep apnea
- High-risk cardiovascular disease
🇺🇸 Approved in United States as Bariatric Surgery for:
- Severe obesity (BMI ≥35 kg/m2) with comorbidities
- Type 2 diabetes
- Hypertension
- Sleep apnea
- High-risk cardiovascular disease
🇨🇦 Approved in Canada as Bariatric Surgery for:
- Severe obesity (BMI ≥35 kg/m2) with comorbidities
- Type 2 diabetes
- Hypertension
- Sleep apnea
- High-risk cardiovascular disease
🇦🇺 Approved in Australia as Bariatric Surgery for:
- Severe obesity (BMI ≥35 kg/m2) with comorbidities
- Type 2 diabetes
- Hypertension
- Sleep apnea
- High-risk cardiovascular disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Princess Margaret HospitalToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Bariatric Surgery: Does It Play a Role in Fertility-Preserving Treatment Among Obese Young Women With Endometrial Cancer? [2019]We present the case of a 17-year-old nulliparous woman with a history of obesity (body mass index 36.2 kg/m(2)), type 2 diabetes, and polycystic ovary syndrome, who was diagnosed with grade 1 endometrioid adenocarcinoma without radiological evidence of myometrial invasion or metastatic disease. After failure of a fertility-preserving treatment with a levonorgestrel-releasing intrauterine device, bariatric surgery was proposed to treat the obesity and improve control of her type 2 diabetes in an attempt to increase the chances of obtaining response to local treatment. Nine months after laparoscopic sleeve gastrectomy and 18 months after insertion of the intrauterine device, the patient reached normal body weight (body mass index 20.3 kg/m(2)) and showed complete response to treatment. As far as we know, this is the first published case of an adolescent obese patient treated with bariatric surgery concomitantly with fertility-preserving management of endometrial cancer. We propose that bariatric surgery may play a role as an adjuvant therapy in fertility-preserving treatment of endometrial cancer with local progestin, in which it could enhance remission rates and reduce recurrence.
Endometrial cancer and bariatric surgery: A scoping review. [2020]Endometrial cancer is strongly associated with obesity, and weight reduction has been demonstrated to decrease risk and overall mortality. Bariatric surgery results in the most dramatic weight loss among morbidly obese individuals, and the impact of bariatric surgery on endometrial cancer requires further investigation.
Bariatric surgery after failed conservative management in a morbidly obese patient with endometrial cancer. [2020]•Extreme obesity may preclude patients from primary surgical management of endometrial cancer.•Bariatric surgery is a safe and effective method of rapid weight loss in patients with extreme obesity.•Delayed hysterectomy, after weight loss from bariatric surgery, is an option in select patients with endometrial cancer.
Morbidly obese patient with endometrial cancer treated by bariatric surgery to enable cancer treatment. [2023]The case demonstrates the use of bariatric surgery to improve a patient's candidacy for surgical treatment for endometrial cancer (EC). A 50-year-old morbidly obese woman with early-stage EC was initially treated with levonorgestrel-releasing intrauterine system (52 mg) . She had to reduce her body mass index (BMI) to become eligible for definite EC treatment. Using conservative methods, she was unable to lose weight effectively. She then underwent bariatric surgery that reduced her BMI from 71.3 to 54.3 kg/m2 She maintained her weight and was eligible for total hysterectomy and bilateral salpingo-oopherectomy. Her procedure was successful and had no complications. She has 6-monthly follow-ups, and the most recent review showed no evidence of recurrence.
Does Bariatric Surgery Affect the Incidence of Endometrial Cancer Development? A Systematic Review. [2019]Obesity has been linked to an increased prevalence in multiple cancers. Studies have suggested a reduction in the overall risk of cancer after bariatric surgery. We reviewed the evidence for bariatric surgery reducing the risk of endometrial cancer. Data was extracted from PubMed, EMBASE, and Medline to perform a systematic review. Thirty-one full text articles were identified from 265 abstracts. Nine observational studies were relevant to endometrial cancer. In the five controlled studies, 462 of 113,032 (0.4%) patients receiving bariatric surgery versus 11,997 of 848,864 (1.4%) controls developed endometrial cancer, odds ratio of 0.317 (95% CI 0.161 to 0.627) using random effects model (P
[Nutritional status after surgical treatment of obesity]. [2008]Biliopancreatic bypass with duodenal switch is a treatment for morbid obesity that combines restriction of dietary intake with a high degree of malabsorption. The operation involves the risk of losing important nutritional elements.
Duodenal stump leak following a duodenal switch: A case report. [2020]Duodenal switch (DS) is a superior choice for surgical weight loss in the super obese patient population. However, there is an associated risk of adverse events following a DS procedure including vitamin deficiencies, bleeding, obstruction, stricture, and leakage.
Clinical outcomes of duodenal switch with a 200-cm common channel: a matched, controlled trial. [2022]Biliopancreatic diversion with duodenal switch (BPD-DS) with a 100-cm common channel has been our treatment of choice for morbid obesity since the early 1990s. This procedure offers excellent long-term weight loss but can be associated with significant side effects.
Duodenal Switch Combined with Systematic Post-operative Supplementation and Regular Patient Follow-up Results in Good Nutritional Outcomes. [2022]The duodenal switch is the most effective bariatric surgical procedure. Due to technical demands of the surgery and concerns regarding high rates of post-operative nutritional sequelae, many surgeons remain hesitant to adopt this technique.
Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. [2018]Gastric bypass and duodenal switch are currently performed bariatric surgical procedures. Uncontrolled studies suggest that duodenal switch induces greater weight loss than gastric bypass.