Weight Loss Management in Endometrial Cancer Survivors (ECS Weight)

October 23, 2025 updated by: Melissa Javellana, University of Kansas Medical Center

Enacting Active Survivorship: Implementation of Weight Management Strategies in Endometrial Cancer Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Sub-Investigator:
          • Ian Cook, MD
        • Contact:
        • Principal Investigator:
          • Melissa Javellana, MD
        • Sub-Investigator:
          • Yasmin Abedin, MD
        • Sub-Investigator:
          • Johanna Finkle, MD
        • Sub-Investigator:
          • Andrea Jewell, MD
        • Sub-Investigator:
          • Lori Spoozak, MD
        • Sub-Investigator:
          • Rana Aliani, MD
        • Sub-Investigator:
          • Thomas Chavez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Survivors of low-risk early-stage endometrial cancer up to 36 months post primary treatment with body mass index (BMI) ≥30 kg/m^2

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endometrial cancer survivors with weight management
Survivors of low-risk early-stage endometrial cancer up to 36 months post primary treatment with body mass index (BMI) ≥30 kg/m2
Behavioral: Weight loss with pharmacotherapy
Patients will meet with a weight management specialist and discuss their options for weight loss including medications (GLP-1 agonist, naltrexone/bupropion, orlistat, or phentermine/topiramate) or bariatric surgery.
Other Names:
  • Weight loss medications
Behavioral: Weight loss without pharmacotherapy
Participants not on medications will have their weight recorded at subsequent cancer surveillance or other routine medical visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants referred to weight loss clinic who are able to start weight management medications
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications
Time Frame: 12 months
We will measure HgA1c (%) at baseline and after 6 and 12 months of medication use.
12 months
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
Time Frame: 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.
12 months
Change in depression as assessed by Patient Health Questionnaire-2 (PHQ-2) over 12 months in participants on weight loss medications
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

October 23, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00160821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD collected throughout the trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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