ISRCTN39207707进行中（未招募）未知
Pre-operative intentional weight loss to support post-operative recovery in patients with overweight and colorectal cancer: the CARE feasibility randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37525408/ (added 21/08/2023) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38969979/ Participants' perspectives (added 08/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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. Listed for curative elective colorectal resection for cancer
- •6. If neoadjuvant treatment is indicated, it must have been completed
- •7. Performance status 0-2
排除标准
- •Current exclusion criteria as of 20/11/2023:
- •The participant may not enter the study if ANY of the following apply:
- •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 warfarin
- •9. Currently on insulin with a previous episode of diabetic ketoacidosis
- •10. Radiological suspicion of imminent intestinal obstruction or endoscopic evidence of an impassable tumour
- •11. Pregnancy, breastfeeding, or planning pregnancy during the course of the trial
- •12. 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
- •13. Currently taking part in other interventional clinical trials unless agreed in advance by all trial teams (participation in observational studies is allowed)
- •A list of trials that co-enrolment has been agreed upon by all trial teams and a list of trials that co-enrolment has been agreed not to be allowed will be regularly updated and provided to trial sites.
- •Previous exclusion criteria:
- •The participant may not enter the study if ANY of the following apply:
- •1. =10% self-reported weight loss in the 6 months before the screening visit
- •2. <20 days from the screening visit until surgery
- •3. Follows an exclusively vegan diet, has lactose intolerance or has an 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 warfarin
- •9. Pregnancy, breastfeeding, or planning pregnancy during the course of the trial
- •10. 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.
- •11. Currently taking part in other interventional clinical trials unless agreed in advance by all trial teams (participation in observational studies is allowed).
- •A list of trials that co-enrolment has been agreed upon by all trial teams and a list of trials that co-enrolment has been agreed not to be allowed will be regularly updated and provided to trial sites.
研究者
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