Early Stage Endometrial Cancer, Endometrial Cancer Survivors, Weight Management
Conditions
Keywords
Endometrial Cancer, Endometrial Cancer Survivors, Weight Management, GLP-1 agonist, naltrexone/bupropion, orlistat, phentermine/topiramate
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.
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
Sponsors
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants referred to weight loss clinic who are able to start weight management medications | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications | 12 months | We will measure HgA1c (%) at baseline and after 6 and 12 months of medication use. |
| 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 | 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. |
| Change in depression as assessed by Patient Health Questionnaire-2 (PHQ-2) over 12 months in participants on weight loss medications | 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. |
Countries
United States
Outcome results
None listed