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Weight Loss Management in Endometrial Cancer Survivors (ECS Weight) 50

Recruiting
Clinical Trial NCT06877572 (ECS Weight) is an observational study for Endometrial Cancer Survivors, Weight Management, Early Stage Endometrial Cancer that is recruiting. It started on March 25, 2025 with plans to enroll 50 participants. Led by University of Kansas Medical Center, it is expected to complete by October 1, 2030. The latest data from ClinicalTrials.gov was last updated on October 27, 2025.
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 manag...

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Official Title

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

Conditions
Endometrial Cancer SurvivorsWeight ManagementEarly Stage Endometrial Cancer
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • ECS Weight
  • STUDY00160821
NCT ID Number
NCT06877572
Start Date (Actual)
2025-03-25
Last Update Posted
2025-10-27
Completion Date (Estimated)
2030-10
Enrollment (Estimated)
50
Study Type
Observational
Status
Recruiting
Keywords
Endometrial Cancer
Endometrial Cancer Survivors
Weight Management
GLP-1 agonist
naltrexone/bupropion
orlistat
phentermine/topiramate
Arms / Interventions
Participant Group/ArmIntervention/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
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.
Weight loss without pharmacotherapy
Participants not on medications will have their weight recorded at subsequent cancer surveillance or other routine medical visits
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Percentage of participants referred to weight loss clinic who are able to start weight management medications
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 MeasureMeasure DescriptionTime Frame
Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications
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
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
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • ≥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

  • 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
University of Kansas Medical Center logoUniversity of Kansas Medical Center226 active studies to explore
Study Responsible Party
Melissa Javellana, Principal Investigator, Principal Investigator, University of Kansas Medical Center
Study Central Contact
Contact: Principal Investigator, 913-588-0885, [email protected]
Contact: Co-investigator, 913-588-1593, [email protected]
1 Study Locations in 1 Countries

Kansas

University of Kansas Medical Center, Kansas City, Kansas, 66160, United States
Principal Investigator, Contact, 913-588-0885, [email protected]
Melissa Javellana, MD, Principal Investigator
Yasmin Abedin, MD, Sub-Investigator
Ian Cook, 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, Sub-Investigator
Recruiting