Endometrial Cancer SurvivorsECS WeightNCT06877572
Weight Loss Management in Endometrial Cancer Survivors
An observational study of Endometrial Cancer Survivors and Weight Management, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer Survivors, Weight Management, Early Stage Endometrial Cancer
- What is being tested?
- Weight loss with pharmacotherapy and Weight loss without pharmacotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to Oct 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- ≥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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Enacting Active Survivorship: Implementation of Weight Management Strategies in Endometrial Cancer Survivors
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.
Read more
- 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.
- Being tested
- Weight loss with pharmacotherapy, Weight loss without pharmacotherapy
- Keywords
- Endometrial Cancer, Endometrial Cancer Survivors, Weight Management, GLP-1 agonist, naltrexone/bupropion, orlistat, phentermine/topiramate
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss with pharmacotherapyBehavioural
Also called Weight loss medications
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.
Weight loss without pharmacotherapyBehavioural
Participants not on medications will have their weight recorded at subsequent cancer surveillance or other routine medical visits
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Weight loss with pharmacotherapy; Behavioral: Weight loss without pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start25 Mar 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Endometrial Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Javellana, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877572
- Sponsor's protocol ID
- STUDY00160821
- Acronym
- ECS Weight
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Publications
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 37905277Tondt, 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 36336720Lonneman DJ Jr, Rey JA, McKee BD. Phentermine/Topiramate extended-release capsules (qsymia) for weight loss. P T. 2013 Aug;38(8):446-52.
PubMed 24222976Jain 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 21731866Kulak-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 34336024Ussher 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 36977782Gao 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 36188627Collins 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 31855395Agnew 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 36971688Aleksandrova 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 23824948Petersen 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 36589506Ward 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 22507532Soisson 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 29741696Guh 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 19320986
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enacting Active Survivorship: Implementation of Weight Management Strategies in Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT06877572
- Acronym / sponsor ID
- ECS Weight / STUDY00160821
- Keywords
- Endometrial Cancer, Endometrial Cancer Survivors, Weight Management, GLP-1 agonist, naltrexone/bupropion, orlistat, phentermine/topiramate
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial cancer survivors with weight management | – | Behavioral: Weight loss with pharmacotherapy, Behavioral: Weight loss without pharmacotherapySurvivors of low-risk early-stage endometrial cancer up to 36 months post primary treatment with body mass index (BMI) ≥30 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- ≥18 years old
- ECOG 0-2
- BMI ≥ 30kg/m2
- Completed surgical staging with no evidence of residual disease
- Endometrioid endometrial adenocarcinoma, p53 wild type
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss with pharmacotherapyAlso: Weight loss medicationsPatients 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. | Behavioural | Endometrial cancer survivors with weight management |
| Weight loss without pharmacotherapyParticipants not on medications will have their weight recorded at subsequent cancer surveillance or other routine medical visits | Behavioural | Endometrial cancer survivors with weight management |
Primary outcome
Percentage of participants referred to weight loss clinic who are able to start weight management medications
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 37905277Klair 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.
- BackgroundTondt, J., et al., Obesity Algorithm eBook, presented by the Obesity Medicine Association. 2023.
- Background: PubMed 36336720Eisenberg 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.
- Background: PubMed 24222976Lonneman DJ Jr, Rey JA, McKee BD. Phentermine/Topiramate extended-release capsules (qsymia) for weight loss. P T. 2013 Aug;38(8):446-52.
- Background: PubMed 21731866Jain 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.
- Background: PubMed 34336024Kulak-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.
- Background: PubMed 36977782Ussher 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.
- Background: PubMed 36188627Gao 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.
- Background: PubMed 31855395Collins 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/
- Background: PubMed 36971688Agnew 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.
- Background: PubMed 23824948Aleksandrova 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.
- Background: PubMed 36589506Petersen 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.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer Survivors and Weight Management, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants referred to weight loss clinic who are able to start weight management medications (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06877572, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.