Hysterectomy and Weight Loss Surgery for Endometrial Cancer

Recruiting at 1 trial location

Overseen By Colleen Feltmate, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Pregnancy, Active smoking, Substance abuse, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY for endometrial cancer?

Research shows that bariatric surgery (weight loss surgery) is a safe and effective way to achieve rapid weight loss in extremely obese patients, which can make them eligible for further cancer treatment like hysterectomy (removal of the uterus). Additionally, laparoscopic surgery (a minimally invasive surgery using small incisions) for endometrial cancer in obese patients has been shown to reduce complications and improve recovery compared to open surgery. ^{1 2 3 4 5}

Is concurrent hysterectomy and weight loss surgery safe for humans?

Bariatric surgery (weight loss surgery) is considered safe and effective for rapid weight loss in extremely obese patients, which can help in managing endometrial cancer. However, specific safety data on performing hysterectomy and weight loss surgery at the same time is not well-documented in the available research. ^{3 4 5 6 7}

How is the treatment of concurrent laparoscopic hysterectomy and weight loss surgery unique for endometrial cancer?

This treatment is unique because it combines a hysterectomy (removal of the uterus) with bariatric surgery (weight loss surgery) in one procedure, which can be particularly beneficial for patients with endometrial cancer who are also morbidly obese. This approach not only addresses the cancer but also helps in significant weight reduction, potentially improving overall health and eligibility for cancer treatment. ^{2 3 4 5 8}

What is the purpose of this trial?

To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients).

Research Team

Colleen Feltmate, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adult women with a diagnosis of grade 1 endometrial cancer or EIN, who are obese (BMI of 35-40 with severe obesity-related conditions or BMI ≥ 40). They must be able to read English consent forms and agree to participate. Excluded are those under 18, pregnant, smokers, have had previous bariatric surgery, active substance abuse issues, certain psychiatric conditions, or higher-grade cancer.

Inclusion Criteria

My biopsy shows I have grade 1 endometrial cancer or EIN.

My BMI is over 35 with serious health issues or over 40.

I have a health condition like diabetes, high blood pressure, or severe obesity, or my BMI is 40 or more.

Exclusion Criteria

Pregnant participants

Inability to read an English informed consent form

Unwillingness to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-surgery Preparation

Schedule a series of appointments with a bariatric surgeon, nutritionist, and psychologist as part of the approval process for weight loss surgery

2 weeks

Multiple visits (in-person)

Concurrent Surgery

Hysterectomy and weight loss surgery scheduled on the same day within 8 weeks from first visit with the gynecologic oncologist for endometrial cancer or 12 weeks for EIN patients

1 day

1 visit (in-person)

Post-operative Follow-up

Series of post-operative visits with the bariatric surgeon, gynecologic oncologic surgeon, nutritionist, and psychologist

3 weeks

Multiple visits (in-person)

Long-term Follow-up

Participants are monitored for changes in lab values reflecting comorbid conditions and postoperative weight loss

6 months to 1 year

Treatment Details

Interventions

• CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY

Trial Overview The study tests the feasibility of quickly referring patients diagnosed with obesity and early-stage endometrial cancer or EIN for concurrent weight loss surgery and hysterectomy within an eight-week period from their first oncology appointment.

Participant Groups

Group I: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY Experimental Treatment 1 Intervention

Upon enrollment in the study at first appointment with gynecologic oncologist, referral to the BWH Center for Metabolic and Bariatric Surgery (CMBS). * Schedule a series of appointments with a bariatric surgeon, nutritionist and psychologist, which is part of the approval process for weight loss surgery. * Hysterectomy and weight loss surgery will then be scheduled on the same day within 8 weeks from first visit with the gynecologic oncologist for endometrial cancer or 12 weeks if you have endometrial pre-cancer. * Series of post-operative visits with the bariatric surgeon and gynecologic oncologic surgeon as well as the nutritionist and psychologist.

CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY is already approved in United States, European Union for the following indications:

Approved in United States as Concurrent Laparoscopic Hysterectomy and Bariatric Surgery for:

• Obesity-related endometrial carcinoma
• Endometrial intraepithelial neoplasia (EIN)

Approved in European Union as Concurrent Laparoscopic Hysterectomy and Bariatric Surgery for:

• Obesity-related endometrial carcinoma
• Endometrial intraepithelial neoplasia (EIN)

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Findings from Research

In a study of 61 endometrial cancer patients with obesity, laparoscopic surgery significantly improved surgical outcomes compared to open surgery, leading to reduced intraoperative blood loss.

The laparoscopic approach also resulted in shorter recovery times, less need for pain medication, and a threefold decrease in postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Laparoscopic radical hysterectomy with pelvic lymph node dissection for endometrial cancer in obese patients]. Berlev, IV., Urmancheeva, AF., Saparov, AB., et al.[2014]

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]

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]

In a study of 171 women with endometrial cancer, those who underwent bariatric surgery (POST group) were more likely to have adenocarcinoma and received minimally invasive hysterectomies compared to those who did not have surgery (PRE group).

Despite the differences in tumor characteristics, the 5-year overall survival rate was significantly lower in the POST group (77.8%) compared to the PRE group (98%), indicating that bariatric surgery did not improve cancer outcomes, and further research is needed to clarify its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Bariatric Surgery on Endometrial Cancer Tumor Pathology. Mahvi, DA., Foley, OW., Ardestani, A., et al.[2021]

Women with a history of bariatric surgery experienced significantly fewer complications and shorter hospital stays after hysterectomy compared to those without such a history, based on a matched analysis of 1,785 patients.

This study suggests that bariatric surgery may be beneficial for women with a body mass index ≥40 kg/m2 who require a non-urgent hysterectomy, as it appears to improve surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric surgery reduces odds of perioperative complications after inpatient hysterectomy: Analysis from a national database, 2016 to 2018. Young, MC., Bhandarkar, AR., Portela, RC., et al.[2023]

In a study of 2271 women undergoing laparoscopic hysterectomy, obesity (defined as a BMI of ≥30 kg/m²) did not significantly impact the safety or feasibility of the procedure, as evidenced by similar operative times, conversion rates, and complication rates between obese and non-obese patients.

The overall complication rates were comparable, with 14.03% for non-obese and 13.66% for obese patients, suggesting that experienced surgeons can perform laparoscopic hysterectomies safely regardless of the patient's weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's the impact of the obesity on the safety of laparoscopic hysterectomy techniques? Kondo, W., Bourdel, N., Marengo, F., et al.[2012]

In a study of 42 obese patients with early-stage endometrial cancer, those who underwent robotic hysterectomy experienced significantly less intraoperative bleeding and shorter hospital stays compared to those who had laparoscopic hysterectomy.

Both surgical methods had similar operation times and lymph node harvests, indicating that robotic surgery may offer advantages in recovery without compromising the effectiveness of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Versus Robotic Hysterectomy in Obese Patients With Early-stage Endometrial Cancer: A Single-centre Analysis. Yoshida, K., Kondo, E., Nimura, R., et al.[2021]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Laparoscopic radical hysterectomy with pelvic lymph node dissection for endometrial cancer in obese patients]. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Morbidly obese patient with endometrial cancer treated by bariatric surgery to enable cancer treatment. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Endometrial cancer and bariatric surgery: A scoping review. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Bariatric surgery after failed conservative management in a morbidly obese patient with endometrial cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of Bariatric Surgery on Endometrial Cancer Tumor Pathology. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Bariatric surgery reduces odds of perioperative complications after inpatient hysterectomy: Analysis from a national database, 2016 to 2018. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

What's the impact of the obesity on the safety of laparoscopic hysterectomy techniques? [2012]

8. Greece pubmed.ncbi.nlm.nih.gov

Laparoscopic Versus Robotic Hysterectomy in Obese Patients With Early-stage Endometrial Cancer: A Single-centre Analysis. [2021]