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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Changes in lab values reflecting comorbid conditions
Post Operative 12-item Short Form Healthy Survey (SF-12) Survey
Postoperative complications
+4 more

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.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,950 Total Patients Enrolled
9 Trials studying Endometrial Cancer
1,506 Patients Enrolled for Endometrial Cancer
Colleen Feltmate, MDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04839614 — N/A
Endometrial Cancer Research Study Groups: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY
Endometrial Cancer Clinical Trial 2023: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY Highlights & Side Effects. Trial Name: NCT04839614 — N/A
CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04839614 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to be enrolled in this trial?

"Clinicaltrials.gov reports that this trial is currently enlisting volunteers, which began on August 1st 2021 and was recently modified on August 2nd 2022."

Answered by AI

How many individuals are being granted the opportunity to partake in this research?

"Affirmative. Clinicaltrials.gov has data verifying that this clinical trial, which was originally launched on August 1st 2021, is currently recruiting volunteers. The requirement stands at 30 individuals from 2 different medical centres."

Answered by AI

What are the foremost aims of this research endeavor?

"This clinical trial is measuring its primary outcome - the percentage of patients that undergo concurrent surgeries within two months (or twelve weeks for EIN participants) - over a period of around 2 Weeks. Secondary outcomes include postoperative weight loss, time under anesthesia, and total operating room duration; these will be evaluated using either paired t-tests or Wilcoxon rank sum tests to compare pre- and post-surgical results as well as survey responses against national complication rates in order to assess safety for the patient population."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Colleen Feltmate, MD 2021. "Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04839614.
All > Weight Loss Boston
~2 spots leftby Jun 2024
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