Clinical trial NCT06877572: Weight Loss Management in Endometrial Cancer Survivors
Official title: Enacting Active Survivorship: Implementation of Weight Management Strategies in Endometrial Cancer Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer Survivors
Weight Management
Early Stage Endometrial Cancer
Keywords: Endometrial Cancer
Endometrial Cancer Survivors
Weight Management
GLP-1 agonist
naltrexone/bupropion
orlistat
phentermine/topiramate
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of low-risk early-stage endometrial cancer up to 12 months post primary treatment with body mass index (BMI) ≥30 kg/m\^2

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants referred to weight loss clinic who are able to start weight management medications
timeFrame: 12 months
Secondary outcomes:
measure: Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Change in depression as assessed by Patient Health Questionnaire-2 (PHQ-2) over 12 months in participants on weight loss medications
timeFrame: 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
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