Weight Loss Management for Endometrial Cancer

(ECS Weight Trial)

Overseen By Principal Investigator

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: GLP-1 agonists, Insulin

Disqualifiers: Stroke, Heart attack, Liver, Kidney, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help endometrial cancer survivors manage their weight, focusing on those dealing with obesity. Researchers seek to understand how a team of health professionals can support these patients in a weight management program, which may include weight loss medications. Patients can choose to use these medications, and the trial will track their progress through routine medical records. The trial will also explore why some patients opt for medication while others do not. This study targets individuals who have survived early-stage endometrial cancer, completed their initial treatment, and have a BMI of 30 or higher. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on a GLP-1 agonist or insulin.

What prior data suggests that this weight management program is safe for endometrial cancer survivors?

Research has shown that weight loss treatments for endometrial cancer survivors are generally safe. Studies have found that surgical weight loss methods can lead to significant weight loss and lower the risk of developing additional health problems. These procedures are effective and can even reduce the need for future medical care. Another study found that joining a behavioral weight loss program helped survivors lose a significant amount of weight.

While specific safety details about weight loss medications were not highlighted, surgical and behavioral weight loss methods have been well-tolerated by patients. If medications are considered, routine care will include monitoring to ensure safety. Patients should always consult their doctors to find the safest option for their individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on weight management specifically for endometrial cancer survivors who have a BMI of 30 or more. Unlike traditional weight loss programs, which may not consider the unique needs of cancer survivors, this approach is tailored to individuals who have undergone treatment for early-stage endometrial cancer. The trial aims to find out how targeted weight management can improve health outcomes and quality of life for these survivors, potentially offering a more effective and supportive option than general weight loss strategies.

What evidence suggests that weight loss management is effective for endometrial cancer survivors with obesity?

Research has shown that losing weight can benefit endometrial cancer survivors. In this trial, participants will join a weight management program. Studies have found that those in weight loss programs lost significant weight, improving health by reducing obesity-related risks. Additionally, evidence suggests that weight loss surgery can lead to substantial weight reduction, potentially lowering the risk of other health issues. While some studies indicate that weight loss did not directly affect survival rates, it remains beneficial for managing future health risks. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

My surgery showed no remaining cancer.

My cancer is a specific type of uterine cancer without p53 mutations.

My cancer is in the early stage (Stage 1).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Management Program

Participants are referred to the KUMC OB/Gyn weight management clinic to discuss weight management options and potentially start weight loss medication

12 months

Regular visits as part of routine monitoring

Follow-up

Participants are monitored for changes in insulin resistance, quality of life, and depression over 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Weight Loss Management

How Is the Trial Designed?

Group I: Endometrial cancer survivors with weight management Experimental Treatment 2 Interventions

Survivors of low-risk early-stage endometrial cancer up to 36 months post primary treatment with body mass index (BMI) ≥30 kg/m2

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408227/

Obesity management in the setting of endometrial cancer and ... Weight loss surgery is associated with reduced cancer risk and improvements in molecular markers, though findings on specific biomarkers remain ...

2. spandidos-publications.com spandidos-publications.com/10.3892/ol.2023.14177

Impact of weight loss after treatment on survival outcomes ... Even if greater weight loss is observed in patients with endometrial cancer that survive the disease, no significant impact on survival outcomes is observed.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352578921002010

Effectiveness of profile by Sanford behavioral weight loss ... This study showed that participants enrolled in the Profile BWL program lost significantly more weight than those in the matched control group who received ...

4. cancernetwork.com cancernetwork.com/view/behavioral-weight-loss-program-successful-among-survivors-of-endometrial-cancer

Behavioral Weight Loss Program Successful Among ... Endometrial cancer survivors experienced clinically significant weight loss after participating in a behavioral weight loss program.

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)35830-2/fulltext

The obese endometrial cancer patient: how do we ... Current data clearly demonstrate that bariatric surgery can result in clinically significant weight loss that not only reduces the risk of development of ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24031451

Endometrial Cancer Survivors' Perceptions of Provider ... One third of endometrial cancer survivors report counseling by their GO to lose weight. One half of endometrial cancer survivors reported attempted weight loss.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.5607

Impact of surgical weight loss treatments on care burden ... Surgical weight loss achieves rapid and effective weight loss and has the potential to lower healthcare utilization among EC survivors.