Weight Loss Management in Endometrial Cancer Survivors

Recruiting

• Conditions: Endometrial Cancer Survivors; Weight Management; Early Stage Endometrial Cancer

• Registration Number: NCT06877572
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

This study is being done to understand how oncologists can engage a multidisciplinary team to help endometrial cancer survivors with obesity to engage in a weight management program and potentially start a weight loss medication. Obesity often impacts the future health and longevity of early-stage endometrial cancer survivors more than their cancer diagnosis.

Patients will be referred to the KUMC OB/Gyn weight management clinic to discuss weight management options.

* If patients decide to use medications for weight loss, then the study will collect data from their chart that is recorded as part of routine monitoring for patients on weight loss medications.

* If patients decide not to use any medications, the study will monitor physical exam and lab data collected as part of their routine medical care.

The study will also try to understand reasons why patients did or did not start using a weight loss medication.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-14
• Study Start: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2028-10
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• ≥18 years old
• ECOG 0-2
• BMI ≥ 30kg/m2
• Completed surgical staging with no evidence of residual disease
• Endometrioid endometrial adenocarcinoma, p53 wild type
• Stage 1
• Undergoing active surveillance +/- brachytherapy

Exclusion Criteria

• Unable to participate in behavior weight loss
• Stroke, heart attack, end stage liver disease, or end stage kidney disease during the last 6 months.
• Currently on a GLP-1 agonist
• Currently on insulin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants referred to weight loss clinic who are able to start weight management medications	12 months	We will track the number of participants who do and do not start medication. Patients will be offered GLP-1 agonist, naltrexone/bupropion, orlistat, or phentermine/topiramate based discussion with weight management specialist.

Secondary Outcome Measures

Name	Time	Method
Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications	12 months	We will measure HgA1c (%) at baseline and after 6 and 12 months of medication use.
Change in quality of life as assessed by the Functional Assessment of Cancer Therapy- Gynecology (FACT-G) over 12 months in participants on weight loss medications	12 months	FACT-G will be assessed at baseline, 6, and 12 months after starting medication. The score ranges from 0-108 with higher scores indicating better quality of life.
Change in depression as assessed by Patient Health Questionnaire-2 (PHQ-2) over 12 months in participants on weight loss medications	12 months	PHQ-2 will be assessed at baseline, 6, and 12 months after starting medication. The score ranges from 0-6 with lower scores indicating less depressive symptoms. Patients with a score of 3 or greater will be further assessed with Patient Health Questionnaire-9 and managed per a protocol already in place for all weight loss clinic patients.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States