Weight Loss Management in Endometrial Cancer Survivors

NCT06877572 | Recruiting

• 1 other identifier: STUDY00160821
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications

  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

  12 months

• Change in depression as assessed by Patient Health Questionnaire-2 (PHQ-2) over 12 months in participants on weight loss medications

  12 months

Study Arms (1)

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; Behavioral: Weight loss without pharmacotherapy

Interventions

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.

Also known as: Weight loss medications

Endometrial cancer survivors with weight management

Weight loss without pharmacotherapy BEHAVIORAL

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

Endometrial cancer survivors with weight management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Publications (19)

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  PMID: 37905277 BACKGROUND

• Tondt, J., et al., Obesity Algorithm eBook, presented by the Obesity Medicine Association. 2023.

  BACKGROUND

• Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, de Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery. Obes Surg. 2023 Jan;33(1):3-14. doi: 10.1007/s11695-022-06332-1.

  PMID: 36336720 BACKGROUND

• Lonneman DJ Jr, Rey JA, McKee BD. Phentermine/Topiramate extended-release capsules (qsymia) for weight loss. P T. 2013 Aug;38(8):446-52.

  PMID: 24222976 BACKGROUND

• Jain SS, Ramanand SJ, Ramanand JB, Akat PB, Patwardhan MH, Joshi SR. Evaluation of efficacy and safety of orlistat in obese patients. Indian J Endocrinol Metab. 2011 Apr;15(2):99-104. doi: 10.4103/2230-8210.81938.

  PMID: 21731866 BACKGROUND

• Kulak-Bejda A, Bejda G, Waszkiewicz N. Safety and efficacy of naltrexone for weight loss in adult patients - a systematic review. Arch Med Sci. 2020 Sep 10;17(4):940-953. doi: 10.5114/aoms.2020.96908. eCollection 2021.

  PMID: 34336024 BACKGROUND

• Ussher JR, Drucker DJ. Glucagon-like peptide 1 receptor agonists: cardiovascular benefits and mechanisms of action. Nat Rev Cardiol. 2023 Jul;20(7):463-474. doi: 10.1038/s41569-023-00849-3. Epub 2023 Mar 28.

  PMID: 36977782 BACKGROUND

• Gao X, Hua X, Wang X, Xu W, Zhang Y, Shi C, Gu M. Efficacy and safety of semaglutide on weight loss in obese or overweight patients without diabetes: A systematic review and meta-analysis of randomized controlled trials. Front Pharmacol. 2022 Sep 14;13:935823. doi: 10.3389/fphar.2022.935823. eCollection 2022.

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  PMID: 31855395 BACKGROUND

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  PMID: 36971688 BACKGROUND

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  PMID: 23824948 BACKGROUND

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MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Principal Investigator

CONTACT

913-588-0885; mjavellana@kumc.edu

Co-investigator

CONTACT

913-588-1593; yabedin@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 14, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2030
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)