Combining weight loss surgery with hysterectomy for obese women with endometrial cancer
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
This study is testing whether combining weight loss surgery with a hysterectomy can help obese women with endometrial cancer get better results and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04839614 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a streamlined referral process for obese patients diagnosed with endometrial carcinoma or endometrial intraepithelial neoplasia (EIN) to undergo concurrent laparoscopic hysterectomy and weight loss surgery. The goal is to perform both surgeries within 8 to 12 weeks of the initial appointment with a gynecologic oncologist, depending on the diagnosis. By addressing obesity, which is a significant risk factor for endometrial cancer, the study seeks to improve patient outcomes and reduce obesity-related health issues. Approximately 30 patients will be enrolled at Brigham and Women's Hospital to assess the safety and effectiveness of this combined surgical approach.
Who should consider this trial
Good fit: Ideal candidates are female adults aged 18 and older with a BMI of 35 or higher and a diagnosis of grade 1 endometrial carcinoma or EIN.
Not a fit: Patients with a BMI below 35, those with more advanced cancer diagnoses, or contraindications to bariatric surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced obesity-related health complications for patients with endometrial cancer.
How similar studies have performed: While the combined approach has been performed previously without increased complications, this is the first formal study assessing its feasibility and effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female adults at least 18 years of age * A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities --including T2D,112 hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 4 fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life) OR a BMI ≥ 40 * Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN. Exclusion Criteria: * Younger than 18 years old * BMI \< 35 * Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis * Pregnant participants will be excluded from this study. * Patients with contraindications to bariatric surgery will also be excluded. --This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness * include inability to read an English informed consent form, and unwillingness to provide informed consent.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Colleen Feltmate, MD — Brigham and Women's Hospital
- Study coordinator: Colleen Feltmate, MD
- Email: cfeltmate@bwh.harvard.edu
- Phone: 617-732-8840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.