Womb cancer Cancer
Conditions
Interventions
Following the screening visit, participants will be randomised 1:1 to the supported weight loss group or standard care.
Supported weight loss (intervention)
Participants will be asked to eat only for
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 30/12/2024: 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. For staff: 1. Any research or clinical staff involved in the study and recruitment process For next of kin/friends/carers: 1. Next of kin, friend or carer of a trial participant who has been randomised to the supported weight loss group. 2. Participant is willing and able to give informed consent for participation in the study 3. Able to communicate in English 4. Aged 18 years or above. Previous inclusion criteria: 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. For staff: 1. Any research or clinical staff involved in the study and recruitment process
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 30/12/2024: or patients: 1. > = 10% self-reported weight loss in the 6 months before the screening visit 2. 155 kg. 2. Inability to cycle For staff: 1. No exclusions For next of kin/friend/carers: 1. No exclusions Previous exclusion criteria: 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). For staff: 1. No exclusions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate measured using the number of sites open, the total n participants recruited, and the number of participants recruited per site as documented in the study notes per month at screening. 2. Engagement rate measured using the mean proportion of phone calls answered per participant documented in the study notes throughout the intervention. 3. Adherence rate measured using the proportion of intervention participants with =5% weight loss documented in the study notes from baseline to the day of surgery. 4. Retention rate measured using the proportion of participants documented in the study notes as attending their final follow-up (30 days post-operatively) 5. Safety profile measured using related adverse events and expected related and unexpected related serious adverse events documented in the study notes throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/12/2024: Morbidity will be assessed from patient records at discharge and 30 days postoperatively using the Clavien-Dindo classification as follows: 1. Any morbidity 2. Morbidity by grade (II, IIIa, IIIb, IVa, IVb) Oncological outcomes will be assessed from patient records using: 3. Survival (grade V) assessed at 3 years 4. Fitness to receive planned adjuvant therapy assessed at 30 days post postoperatively 5. Recurrence assessed at 3 years 6. New primary/secondary cancer assessed at 3 years Operative outcomes will be assessed from patient records using: 7. Intraoperative blood loss assessed at discharge 8. Operative time assessed at discharge 9. Conversion to open surgery assessed at discharge 10. Surgical site infection assessed at discharge and 30- days post-operatively 11. Time in the intensive care unit and high-dependency unit assessed at discharge and 30- days post-operatively. 12. Re-operation rates assessed at 30 days post-operatively and 3 years 13. Re-admission rates assessed 30 days post-operatively and 3 years Hospital stay will be assessed from patient records at discharge and 30 days postoperatively using: 16. Length of hospital stay (fitness to discharge) assessed at discharge. 17. Days alive and out of hospital assessed 30 days post-operatively. Anthropometry will be assessed by measuring in-person at baseline, on admission, and 30 days postoperatively using: 18. Weight 19. Fat-free mass Fitness will be assessed by measuring in-person at baseline and 30 days postoperatively using: 20. Time for sit-to-stand test Health-related quality of life will be self-reported at baseline, 4 days preoperatively, and 30 days postoperatively using: 21. EQ-5D-5L 22. HADS Endometrial cancer specific health-related quality of life will be self-reported at 30 days postoperatively using: 23. EORTC-QLQ-EN24 Costs and resource use will be assessed from trial records and by self-report using: 24. Intervention costs assess | — |
Countries
England, United Kingdom
Outcome results
None listed