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RecruitingObservational

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

NCT ID: NCT06877572Sponsor: University of Kansas Medical CenterLast updated: 2025-10-27

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.

Arms & interventions

  • BehavioralWeight 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.

  • BehavioralWeight loss without pharmacotherapy

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

Outcome measures

Primary

  • 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.

    Time frame: 12 months

Secondary

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

    Time frame: 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

  • 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

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160

Recruiting
Principal Investigator · Contact
913-588-0885mjavellana@kumc.edu
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

References

  • Klair N, Patel U, Saxena A, Patel D, Ayesha IE, Monson NR, Ramphall S. What Is Best for Weight Loss? A Comparative Review of the Safety and Efficacy of Bariatric Surgery Versus Glucagon-Like Peptide-1 Analogue. Cureus. 2023 Sep 29;15(9):e46197. doi: 10.7759/cureus.46197. eCollection 2023 Sep.(PubMed)
  • Tondt, J., et al., Obesity Algorithm eBook, presented by the Obesity Medicine Association. 2023.
  • 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.(PubMed)
  • Lonneman DJ Jr, Rey JA, McKee BD. Phentermine/Topiramate extended-release capsules (qsymia) for weight loss. P T. 2013 Aug;38(8):446-52.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • Collins L, Costello RA. Glucagon-Like Peptide-1 Receptor Agonists. 2024 Feb 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551568/(PubMed)
  • Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.(PubMed)
  • Aleksandrova K, Drogan D, Boeing H, Jenab M, Bas Bueno-de-Mesquita H, Jansen E, van Duijnhoven FJ, Rinaldi S, Fedirko V, Romieu I, Kaaks R, Riboli E, Gunter MJ, Romaguera D, Westhpal S, Overvad K, Tjonneland A, Halkjaer J, Boutron-Ruault MC, Clavel-Chapelon F, Lukanova A, Trichopoulou A, Trichopoulos D, Vidalis P, Panico S, Agnoli C, Palli D, Tumino R, Vineis P, Buckland G, Sanchez-Cruz JJ, Dorronsoro M, Diaz MJ, Barricarte A, Ramon Quiros J, Peeters PH, May AM, Hallmans G, Palmqvist R, Crowe FL, Khaw KT, Wareham N, Pischon T. Adiposity, mediating biomarkers and risk of colon cancer in the European prospective investigation into cancer and nutrition study. Int J Cancer. 2014 Feb 1;134(3):612-21. doi: 10.1002/ijc.28368. Epub 2013 Aug 5.(PubMed)
  • Petersen Harrington S, Balmaceda J, Spoozak L, Jewell A, Fitzgerald-Wolff S. Higher baseline BMI and lower estimated median income associated with increasing BMI after endometrial cancer diagnosis. Gynecol Oncol Rep. 2022 Dec 13;44:101123. doi: 10.1016/j.gore.2022.101123. eCollection 2022 Dec.(PubMed)
  • Ward KK, Shah NR, Saenz CC, McHale MT, Alvarez EA, Plaxe SC. Cardiovascular disease is the leading cause of death among endometrial cancer patients. Gynecol Oncol. 2012 Aug;126(2):176-9. doi: 10.1016/j.ygyno.2012.04.013. Epub 2012 Apr 13.(PubMed)
  • Soisson S, Ganz PA, Gaffney D, Rowe K, Snyder J, Wan Y, Deshmukh V, Newman M, Fraser A, Smith K, Herget K, Hanson HA, Wu YP, Stanford J, Al-Sarray A, Werner TL, Setiawan VW, Hashibe M. Long-term Cardiovascular Outcomes Among Endometrial Cancer Survivors in a Large, Population-Based Cohort Study. J Natl Cancer Inst. 2018 Dec 1;110(12):1342-1351. doi: 10.1016/j.ygyno.2017.12.025.(PubMed)
  • Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, Anis AH. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009 Mar 25;9:88. doi: 10.1186/1471-2458-9-88.(PubMed)