This clinical trial studies whether obese or overweight patients with endometrial cancer can conveniently undergo simultaneous weight loss surgery with curative hysterectomy in a timely fashion. The most common risk factor for endometrial cancer is obesity. Weight loss surgery has been shown to help patients lose weight and also decrease their risk for obesity-related diseases. If patients with early-stage endometrial cancer or pre-cancer can undergo hysterectomy and weight loss surgery at the same time, their cancer may be cured and their risk for obesity-related diseases may be greatly decreased.
Additional locations may be listed on ClinicalTrials.gov for NCT04839614.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Colleen Feltmate
Dana-Farber Cancer InstituteStatus: Active
Contact: Colleen Feltmate
PRIMARY OBJECTIVES:
I. To assess the feasibility of an expedited referral process for the obese endometrial cancer or endometrial intraepithelial neoplasia (EIN) patient from her gynecologic oncologist to the hospital associated weight management center in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or within 12 weeks for EIN patients without an levonorgestrel intrauterine device [LIUD] in place or within 6 months for EIN patients from the time of LIUD placement).
II. To evaluate the feasibility of concurrent laparoscopic hysterectomy and weight loss surgery (WLS) in obese women with a tissue diagnosis of endometrial cancer or EIN who follow through with their referral to the hospital associated weight management center.
SECONDARY OBJECTIVES:
I. To evaluate the safety of concurrent laparoscopic hysterectomy and weight loss surgery in obese women with a tissue diagnosis of endometrial cancer or EIN who follow through with their referral to the hospital associated weight management center.
II. To determine whether concurrent surgery improves short-term and long-term obesity-related outcomes (i.e., better diabetes control, lowered cholesterol, lowered baseline blood pressure) in obese women with endometrial cancer or EIN.
TERTIARY OBJECTIVE:
I. To determine whether quality of life is improved 6 months post-operatively compared to preoperatively by bariatric-specific patient-reported outcome (PRO) surveys that include BODYQ and European Quality of Life Five Dimension Five Level Scale (EQ-5D) questions.
OUTLINE:
Patients meet with a bariatric surgeon, nutritionist, and psychologist within 1-2 weeks after enrollment in order to be approved for weight loss surgery. Patients undergo hysterectomy and weight loss surgery within 6-8 weeks (for endometrial cancer) or 8-12 weeks (for EIN without an LIUD) or 6 months (for EIN patients from the time of LIUD placement) after diagnosis and initial consultation. After surgery, patients meet with their bariatric surgeon, advanced practicing provider (APP) and dietitian at 2-3 and 6 weeks, 3, 6, 9, and 12 months post-operation (post-op). Patients also meet with their gynecologic cancer surgeon at 2-3 weeks, 6 and 12 months post-op. Patients also complete a quality of life survey before and after surgery. Patients' medical records are also reviewed.
After completion of study, patients are followed up at 2-3 weeks, 3, 6, 9, and 12 months for up to 5 years.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorColleen Feltmate