Combining weight loss surgery with hysterectomy for obese women with endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.