Pre-operative intentional weight loss to support post-operative recovery in patients with overweight and endometrial cancer: the ENDO-CARE feasibility randomised controlled trial

niversity of Oxford0 个研究点目标入组 72 人开始时间: 2023年10月27日最近更新: 2023年11月13日

适应症

试验速览

暂无简介。

•For patients:
•1. Participant is willing and able to give informed consent for participation in the study.
•2. Able to communicate in English or has a relative/friend/carer acting as interpreter.
•3. Aged 18 years or above.
•4. BMI >= 28 kg/m² (or BMI >= 25 kg/m² for people of Black, Asian, or minority ethnic origin).
•5. Planned for curative elective surgery for endometrial cancer.
•6. Performance status 0-2.
•1. Any research or clinical staff involved in the study and recruitment process

•For patients:
•1. > = 10% self-reported weight loss in the 6 months before the screening visit
•2. < 20 days from the screening visit until surgery.
•3. Having allergy to soy.
•4. Documented stage 4-5 kidney disease.
•5. Documented severe heart failure (defined as New York Heart Association grade 3 or 4).
•6. Previous bariatric surgery.
•7. Type 1 diabetes.
•8. Currently on insulin with a previous episode of diabetes ketoacidosis.
•9. Currently on warfarin.
•10. Pregnancy, breastfeeding, or planning pregnancy during the course of the trial.
•11. Any other significant disease or disorder which, in the opinion of the Investigator or healthcare professional, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
•12. Currently taking part in other interventional clinical trials unless agreed in advance by all trial teams (participation in observational studies is allowed).
•1. No exclusions

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