Endometrial Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Women who have been diagnosed with endometrial (uterine) cancer and are scheduled to have their uterus surgically removed with the goal of curing the cancer
• People between the ages of 21 and 75
• People with a Body Mass Index (BMI) of 30 or higher (considered obese by standard medical classification)
• People who are willing to take part in a stomach procedure called E-ESG along with a structured lifestyle change program
• People who are willing to follow strict, lifelong changes to how and what they eat as required by the procedure
• People who are willing to follow all study requirements, including signing a consent form, attending regular check-up appointments, completing blood and lab tests, and participating in diet counselling
• People who live close enough to the trial location to attend all required follow-up visits
• People who are able to understand and agree to participation in the trial by giving informed consent

Who may not be able to join:

• People who have previously had surgery on the upper digestive system or gastrointestinal (gut) tract, except for a straightforward gallbladder or appendix removal
• People who have had previous gut surgery that caused complications such as blockages, scarring inside the abdomen, or known internal abdominal adhesions (bands of scar tissue)
• People who have previously had any type of weight-loss (bariatric) surgery, whether open or keyhole
• People who have had any prior surgery on the food pipe (oesophagus), stomach, or surgery to repair a hiatal hernia (where part of the stomach pushes up into the chest)
• People with inflammatory conditions of the digestive tract, such as severe inflammation of the food pipe, stomach ulcers, small intestine ulcers, digestive tract cancer, or conditions like Crohn's disease
• People with conditions that could cause bleeding in the upper digestive tract, such as enlarged veins in the food pipe or stomach, or certain abnormalities of blood vessels or structure in the gut
• People with certain stomach tumours, a history of pre-cancerous stomach conditions, or a history of conditions involving abnormal growths in the digestive tract
• People who have a gastric (stomach) mass or stomach polyps larger than 1 centimetre
• People with a hiatal hernia larger than 4 centimetres, or who have severe or hard-to-control acid reflux symptoms
• People with a structural abnormality in the food pipe or throat, such as a narrowing or an outpouching, that could make passing a camera scope difficult
• People with achalasia (a condition where the food pipe cannot move food properly into the stomach) or any other serious disorder affecting movement of food through the oesophagus
• People with severe problems with blood clotting
• People with a serious health condition unrelated to their weight that would make an internal camera (endoscopy) procedure higher risk (confirm with trial site)
• People with movement or motility disorders of the digestive tract, such as significant oesophageal motility problems, delayed stomach emptying (gastroparesis), or severe ongoing constipation
• People with liver failure or cirrhosis (serious liver scarring)
• People who have previously had an intragastric device (a device placed inside the stomach, such as a balloon) which may have thickened the stomach wall and made stitching more difficult
• People with active psychological or mental health conditions that would prevent participation in a lifestyle modification program, as assessed by a psychologist
• People who are unwilling to take part in a medically supervised diet, behaviour change program, and regular medical follow-up
• People who are unable or unwilling to take a prescribed medication called a proton pump inhibitor (a drug that reduces stomach acid)
• People who take daily high-dose aspirin (more than 80 mg per day), anti-inflammatory medications, blood thinners, or other medications that can irritate the stomach
• People who are currently pregnant or breastfeeding
• People with serious heart or lung disease, including a known history of coronary artery disease, a heart attack within the past 6 months, poorly controlled high blood pressure, or a need for regular NSAID (anti-inflammatory painkiller) use
• People taking medications that must be taken at very specific times and whose absorption could be affected by changes in how quickly the stomach empties, such as anti-seizure or heart rhythm medications
• People currently taking corticosteroids (steroid medications), immunosuppressants (medications that lower immune system activity), or strong narcotic pain medications
• People who are currently taking weight-loss pills or diet pills
• People with symptomatic heart failure, irregular heart rhythm, or unstable heart disease
• People with moderate or severe pre-existing lung disease (such as COPD) requiring steroid treatment, active pneumonia, or lung cancer
• People with a diagnosed autoimmune connective tissue disorder such as lupus or scleroderma, or who have a weakened immune system
• People with a specific diagnosed genetic condition such as Prader-Willi syndrome
• People with eating disorders, including night eating syndrome, bulimia, binge eating disorder, or compulsive overeating
• People with a known hormone (endocrine) disorder affecting weight, such as hypothyroidism that is not well controlled

Important: Always verify eligibility with the trial site directly before applying.