Weight Loss Management in Endometrial Cancer Survivors
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Weight loss with pharmacotherapy, Weight loss without pharmacotherapy.
- Кому может быть актуально
- Состояния в реестре: Endometrial Cancer Survivors, Weight Management, Early Stage Endometrial Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Enacting Active Survivorship: Implementation of Weight Management Strategies in Endometrial Cancer Survivors
Обзор
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.
Вмешательства
- Поведенческое 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. - Поведенческое Weight loss without pharmacotherapy
Participants not on medications will have their weight recorded at subsequent cancer surveillance or other routine medical visits
Первичные конечные точки
- Percentage of participants referred to weight loss clinic who are able to start weight management medications [Срок оценки: 12 months]
Вторичные конечные точки (3)
- Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications [Срок оценки: 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 [Срок оценки: 12 months]
- Change in depression as assessed by Patient Health Questionnaire-2 (PHQ-2) over 12 months in participants on weight loss medications [Срок оценки: 12 months]
Критерии участия
Критерии включения
- ≥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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- University of Kansas Medical Center — Kansas City
Публикации
- 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. PMID 37905277
- 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 Disord PMID 36336720
- 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
- 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
- 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
- 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
- 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. PMID 36188627
Идентификаторы
NCT: NCT06877572 · STUDY00160821