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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the practicality of quickly performing both a hysterectomy and weight loss surgery for obese women with early-stage endometrial cancer or a pre-cancer condition. The goal is to conduct these surgeries together within 8-12 weeks of the patient's first appointment with a gynecologic oncologist. Suitable candidates for this trial have a BMI of 35 or higher and a diagnosis of early-stage endometrial cancer or a related pre-cancer condition. Participants should also have a serious weight-related health issue, such as Type 2 diabetes or severe arthritis, that affects their daily life. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options that could improve health and quality of life.

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 prior data suggests that this concurrent laparoscopic hysterectomy and weight loss surgery is safe?

Research has shown that combining a laparoscopic hysterectomy (a surgery to remove the uterus using small cuts) with weight loss surgery is generally safe. Studies have found that this combination not only aids in weight loss but might also improve overall health.

No major safety concerns have been reported specifically for performing these two surgeries together. Both surgeries are known to be safe when performed by skilled surgeons. Patients usually recover well, but like any surgery, there are risks such as infection or bleeding.

This trial examines the practicality of scheduling these surgeries simultaneously. Previous evidence suggests that patients handle them well without major problems. Always consult your doctor to see how this information might relate to you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the concurrent laparoscopic hysterectomy and weight loss surgery for endometrial cancer because it combines two procedures that can be performed together, possibly enhancing patient outcomes. Unlike the standard approach, where a hysterectomy and weight loss surgery might be done separately, this method aims to address cancer treatment and obesity-related health issues at once. By scheduling both surgeries on the same day, within a short timeframe, patients might experience a more streamlined recovery process and potentially improve their overall health more rapidly. This dual approach could lead to better weight management, which is often crucial for reducing cancer recurrence risk and improving long-term health.

What evidence suggests that concurrent laparoscopic hysterectomy and weight loss surgery might be effective for endometrial cancer?

Research has shown that combining weight loss surgery with a hysterectomy, as studied in this trial, may improve metabolic health. Studies have found that weight loss surgery can aid in weight loss and reduce the risk of obesity-related diseases. Early results suggest that this combined approach might help manage metabolic issues in patients with endometrial cancer or pre-cancer. This procedure appears to be a promising way to address both weight and cancer concerns simultaneously. ^{1 3 4 6 7}

Who Is on the Research Team?

Colleen Feltmate, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04839614

Concurrent Laparoscopic Hysterectomy and Weight Loss ... Weight loss surgery has been shown to help patients lose weight and also decrease their risk for obesity-related diseases. This research study is a Feasibility ...

2. dana-farber.org dana-farber.org/clinical-trials/19-419

Concurrent Laparoscopic Hysterectomy and Weight Loss ... Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients with Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia · Trial ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39971420/

Laparoscopic bariatric surgery with hysterectomy for ... Early evidence has suggested that combining bariatric surgery with total laparoscopic hysterectomy may improve the underlying metabolic disease.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825821008726

Cost-effectiveness analysis comparing laparoscopic ... This study is the first to conduct a cost-effectiveness analysis comparing LH to combined LH and bariatric surgery in obese women with ORD undergoing surgery ...

5. international-journal-of-gynecological-cancer.com international-journal-of-gynecological-cancer.com/article/S1048-891X(24)10175-2/pdf

ep373/#1103 concurrent laparoscopic hysterectomy Conclusions Early results demonstrate feasibility of an expe- dited referral process to a bariatric surgeon for obese women with EIN or grade 1 EC. The outcome ...

6. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(24)00751-0/abstract

Concurrent laparoscopic hysterectomy and bariatric ... The primary aim of this trial is to assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-04299

Concurrent Hysterectomy and Weight Loss Surgery in ... This clinical trial studies whether obese or overweight patients with endometrial cancer can conveniently undergo simultaneous weight loss surgery with ...