30 Participants Needed

Hysterectomy and Weight Loss Surgery for Endometrial Cancer

Recruiting at 1 trial location
CF
Overseen ByColleen Feltmate, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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).

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.

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.12345

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.13567

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.13568

Who Is on the Research Team?

CF

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.
See 2 more

Exclusion Criteria

Pregnant participants
Inability to read an English informed consent form
Unwillingness to provide informed consent
See 4 more

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?
1Treatment groups
Experimental Treatment
Group I: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERYExperimental Treatment1 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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Published Research Related to This Trial

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

Citations

1.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Laparoscopic radical hysterectomy with pelvic lymph node dissection for endometrial cancer in obese patients]. [2014]
Morbidly obese patient with endometrial cancer treated by bariatric surgery to enable cancer treatment. [2023]
Endometrial cancer and bariatric surgery: A scoping review. [2020]
Bariatric surgery after failed conservative management in a morbidly obese patient with endometrial cancer. [2020]
Impact of Bariatric Surgery on Endometrial Cancer Tumor Pathology. [2021]
Bariatric surgery reduces odds of perioperative complications after inpatient hysterectomy: Analysis from a national database, 2016 to 2018. [2023]
What's the impact of the obesity on the safety of laparoscopic hysterectomy techniques? [2012]
Laparoscopic Versus Robotic Hysterectomy in Obese Patients With Early-stage Endometrial Cancer: A Single-centre Analysis. [2021]
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