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OpenTrials
Active, not recruiting

NCT Number: NCT06877572

Weight Loss Management 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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Endometrial Cancer Survivors Early Stage Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms Weight Management

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight loss with pharmacotherapy

Behavioral

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

Weight loss without pharmacotherapy

Behavioral

Participants not on medications will have their weight recorded at subsequent cancer surveillance or other routine medical visits

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: ECS Weight

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Mar 14, 2025
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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