Weight Loss Management in Endometrial Cancer Survivors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
ECOG 0-2
BMI ≥ 30kg/m2
Completed surgical staging with no evidence of residual disease
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Weight loss with pharmacotherapy
BehavioralPatients 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.
Weight loss without pharmacotherapy
BehavioralParticipants not on medications will have their weight recorded at subsequent cancer surveillance or other routine medical visits
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Endometrial cancer survivors with weight management2 interventions
Trial outcomes
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.
Time frame
12 monthsSecondary outcomes
1
Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications
We will measure HgA1c (%) at baseline and after 6 and 12 months of medication use.
Time frame
12 months2
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
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.
Time frame
12 months3
Change in depression as assessed by Patient Health Questionnaire-2 (PHQ-2) over 12 months in participants on weight loss medications
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov