Bariatric Surgery for Endometrial Cancer

(B-FiERCE Trial)

Overseen By Tara Zad

Age: 18 - 65

Sex: Female

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bariatric surgery (weight loss surgery), combined with progestin therapy, can enhance treatment for women with early-stage endometrial cancer or complex atypical hyperplasia who wish to preserve fertility. The goal is to determine if significant weight loss reduces cancer recurrence more effectively than progestin alone. Participants will be divided into two groups: one receiving both bariatric surgery and a progestin intrauterine device (IUD), and the other receiving only the progestin IUD. Women with a BMI of 35 or higher, diagnosed with early-stage endometrial cancer or atypical hyperplasia, and who wish to maintain fertility may be suitable for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could improve future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bariatric surgery is generally safe and well-tolerated. It often helps people lose significant weight and reduces the risk of serious weight-related health problems. Studies suggest it is the most effective and long-lasting treatment for obesity and may even offer protection against cancer. Although different types of bariatric surgery may yield varying results, it is overall considered safe for those who qualify.

The progestin intrauterine device (IUD), included in the trial, is also widely used and generally well-tolerated. It commonly helps preserve fertility in women with certain reproductive conditions.

Since these treatments are already used and approved for other conditions, extensive safety information is available. However, discussing potential risks and benefits with healthcare providers remains important before making a decision. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for endometrial cancer, which typically involve surgery, radiation, and chemotherapy, the investigational approach of combining bariatric surgery with a progestin intrauterine device (IUD) offers a novel angle. Researchers are excited about this combination because bariatric surgery targets obesity, a key risk factor for endometrial cancer, potentially reducing cancer risk by addressing its root causes. Meanwhile, the progestin IUD directly provides hormonal therapy, which can help manage cancer growth locally within the uterus. This dual approach could offer a less invasive and more holistic treatment option, possibly improving outcomes for patients who are also dealing with obesity.

What evidence suggests that bariatric surgery could be an effective treatment for endometrial cancer?

Research has shown that weight loss surgery, or bariatric surgery, can result in significant and lasting weight loss. This weight loss can reduce the risk of obesity-related health issues, including some cancers. Weight loss surgery is the most effective long-term treatment for obesity and may also offer cancer protection. In this trial, one group will receive both bariatric surgery and a progestin intrauterine device, while another group will receive only the progestin intrauterine device. Combining weight loss surgery with hormone therapy could yield better and longer-lasting outcomes for women with certain pre-cancerous conditions or endometrial cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Sarah E Ferguson, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Bariatric Surgery

Trial Overview 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.

How Is the Trial Designed?

Group I: Bariatric Surgery and Progestin Intrauterine Device Experimental Treatment 1 Intervention

This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.

Group II: Progestin Intrauterine Device Alone Active Control 1 Intervention

This group will receive a progestin intrauterine device alone.

Bariatric Surgery is already approved in European Union, United States, Canada 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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Bariatric surgery effectively reduced the patient's BMI from 71.3 to 54.3 kg/m2, enabling her to qualify for necessary surgical treatment for early-stage endometrial cancer.

The total hysterectomy and bilateral salpingo-oophorectomy were successful with no complications, and follow-up assessments showed no evidence of cancer recurrence after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidly obese patient with endometrial cancer treated by bariatric surgery to enable cancer treatment. Sharma, N., Ragupathy, K.[2023]

Bariatric surgery significantly reduces the risk of developing endometrial cancer in women with obesity (BMI >30 kg/m²), based on a review of 23 relevant studies.

While there is strong evidence for risk reduction, there is limited research on the use of bariatric surgery as an additional treatment for existing endometrial cancer, highlighting a need for further investigation in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endometrial cancer and bariatric surgery: A scoping review. Aubrey, C., Black, K., Campbell, S., et al.[2020]

Biliopancreatic bypass with duodenal switch led to significant weight loss in patients, dropping from an average of 153.8 kg to 92.7 kg within one year, indicating its efficacy for treating morbid obesity.

However, the procedure is associated with a high risk of nutritional deficiencies and complications, particularly in patients with common channels shorter than 100 cm, suggesting that this surgery should be performed with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutritional status after surgical treatment of obesity]. Tonstad, S., Sundfør, T., Myrvoll, EA.[2008]

Bariatric surgery appears to significantly reduce the risk of developing endometrial cancer, with only 0.4% of patients who underwent surgery developing the cancer compared to 1.4% in the control group, resulting in an odds ratio of 0.317.

The analysis was based on nine observational studies, including data from over 113,000 patients who had bariatric surgery, indicating a strong association but highlighting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Bariatric Surgery Affect the Incidence of Endometrial Cancer Development? A Systematic Review. Winder, AA., Kularatna, M., MacCormick, AD.[2019]

A 17-year-old girl with obesity, type 2 diabetes, and early-stage endometrial cancer underwent laparoscopic sleeve gastrectomy, leading to significant weight loss and complete response to fertility-preserving treatment.

This case suggests that bariatric surgery may enhance the effectiveness of local progestin therapy in treating endometrial cancer while preserving fertility, marking a potential new approach for similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric Surgery: Does It Play a Role in Fertility-Preserving Treatment Among Obese Young Women With Endometrial Cancer? Benito, V., López-Tomassetti, E., Esparza, M., et al.[2019]

Duodenal switch (DS) surgery can be effective for weight loss in super obese patients, but it carries significant risks, including complications like duodenal stump blowout, which can lead to severe postoperative issues such as bleeding and abdominal pain.

Early diagnosis and appropriate management of duodenal stump leaks are crucial, involving stabilization of the patient and surgical repair, to prevent serious complications following the DS procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duodenal stump leak following a duodenal switch: A case report. Nelson, L., Moon, RC., Teixeira, AF., et al.[2020]

In a study of 65 patients followed for 5 years after duodenal switch surgery, the average excess body weight loss was 62%, demonstrating the procedure's effectiveness for long-term weight management.

The surgery also led to high remission rates for obesity-related conditions, with 96% of patients achieving remission from type 2 diabetes, 77% from hypertension, and 84% from dyslipidaemia, while post-operative nutritional deficiencies were lower than expected due to a comprehensive supplementation regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duodenal Switch Combined with Systematic Post-operative Supplementation and Regular Patient Follow-up Results in Good Nutritional Outcomes. Joret, MO., Nanayakkara, A., Kulasegaran, S., et al.[2022]

Duodenal switch surgery resulted in significantly greater weight loss (mean reduction of 24.8 kg/m²) compared to gastric bypass (mean reduction of 17.3 kg/m²) over 2 years, indicating its superior efficacy for weight management in severely obese patients.

While both surgeries improved cardiovascular risk factors similarly, duodenal switch was associated with more adverse events, particularly related to malnutrition, highlighting the need for careful monitoring post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. Søvik, TT., Aasheim, ET., Taha, O., et al.[2018]

Extreme obesity can prevent patients from undergoing primary surgical treatment for endometrial cancer, highlighting the need for alternative approaches.

Bariatric surgery is a safe and effective way to achieve rapid weight loss, making it a viable option for patients with extreme obesity to later undergo delayed hysterectomy for endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric surgery after failed conservative management in a morbidly obese patient with endometrial cancer. Montemorano, L., Smrz, SA., Jalilvand, AD., et al.[2020]

Increasing the common channel length to 200 cm in biliopancreatic diversion with duodenal switch (BPD-DS) resulted in similar weight loss outcomes compared to the standard 100 cm channel, with a follow-up of at least 3 years for 36 patients.

The 200 cm common channel was associated with a lower incidence of severe protein deficiency and hyperparathyroidism, suggesting it may reduce nutritional complications compared to the shorter channel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of duodenal switch with a 200-cm common channel: a matched, controlled trial. Lebel, S., Dion, G., Marceau, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11591725/

Long-Term Cancer Outcomes Following Bariatric Surgery We found that patients who underwent AGB and BPD-DS were more likely to develop cancer compared to those who had RYGB. These findings highlight ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10353499/

Long-term effectiveness, outcomes and complications of ... This review aims to synthesize and summarize the growing evidence on the long-term effectiveness, outcomes and complications of bariatric surgery.

3. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=160

Bariatric Surgery for the Treatment of Morbid Obesity Gastric banding achieves weight loss by gastric restriction, not malabsorption. A band creating a gastric pouch with a capacity of approximately 15 to 30 cc's ...

4. mayoclinic.org mayoclinic.org/tests-procedures/bariatric-surgery/about/pac-20394258

Bariatric surgery Bariatric surgery is done to help you lose extra weight and reduce your risk of possibly life-threatening weight-related health problems.

5. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.943544/full

The role of bariatric and metabolic surgery in ... Metabolic and bariatric surgery is the most effective and durable treatment for obesity, is safe, and may have a protective benefit with respect to cancer ...

6. asmbs.org asmbs.org/wp-content/uploads/2022/08/BCBS_NC_2022.pdf

Bariatric Surgery Biliopancreatic Bypass Diversion with Duodenal Switch (CPT code 43845), which specifically identifies the duodenal switch procedure, was introduced in 2005.