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Procedure

Hysterectomy and Weight Loss Surgery for Endometrial Cancer

N/A

Recruiting

Led By Colleen Feltmate, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN

A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities (including T2D, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 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

Must not have

Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis

Patients with contraindications to bariatric surgery (including active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an expedited referral process for obese endometrial cancer or EIN patients from their gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery can help them have surgery within 8 weeks.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include complications from anesthesia, infection post-surgery, bleeding during or after surgery, blood clots in legs or lungs (VTE), adverse reactions to surgical materials used in procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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My BMI is between 35 and 39.99, and I have one or more severe health issues related to obesity.

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I am a woman and at least 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My endometrial cancer is grade 2 or higher, or not yet tissue-diagnosed.

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I do not smoke, have no history of bariatric surgery, substance abuse, eating disorders, large hernias, or unmanaged mental health issues.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment

proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients)

Secondary study objectives

Changes in lab values reflecting comorbid conditions

Post Operative 12-item Short Form Healthy Survey (SF-12) Survey

Postoperative complications

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met