Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
NIHR Oxford Biomedical Research Centre, Oxford, UK.
Colorectal Dis. 2023 Sep;25(9):1910-1920. doi: 10.1111/codi.16687. Epub 2023 Jul 31.
Excess weight increases the risk of morbidity following colorectal cancer surgery. Weight loss may improve morbidity, but it is uncertain whether patients can follow an intensive weight loss intervention while waiting for surgery and there are concerns about muscle mass loss. The aim of this trial is to assess the feasibility of intentional weight loss in this setting and determine progression to a definitive trial.
CARE is a prospectively registered, multicentre, feasibility, parallel, randomised controlled trial with embedded evaluation and optimisation of the recruitment process. Participants with excess weight awaiting curative colorectal resection for cancer are randomised 1:1 to care as usual or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian. Progression criteria will be based on the recruitment, engagement, adherence, and retention rates. Data will be collected on the 30-day postoperative morbidity, the typical primary outcome of prehabilitation trials. Secondary outcomes will include, among others, length of hospital stay, health-related quality of life, and body composition. Qualitative interviews will be used to understand patients' experiences of and attitudes towards trial participation and intervention engagement and adherence.
CARE will evaluate the feasibility of intensive intentional weight loss as prehabilitation before colorectal cancer surgery. The results will determine the planning of a definitive trial.
超重会增加结直肠癌手术后发病的风险。减肥可能会改善发病率，但尚不确定患者在等待手术期间是否能够进行强化减肥干预，而且人们还担心会损失肌肉量。本试验旨在评估在这种情况下进行有目的的减肥的可行性，并确定是否推进到确定性试验。
CARE 是一项前瞻性注册的、多中心的可行性、平行、随机对照试验，嵌入了对招募过程的评估和优化。正在接受超重且等待根治性结直肠切除术治疗癌症的患者按 1:1 随机分配至常规护理组或低能量营养充足的全饮食替代方案组，每周由营养师提供远程行为支持。进展标准将基于招募、参与、依从性和保留率。将在 30 天的术后发病率方面收集数据，这是预康复试验的典型主要结局。次要结局将包括住院时间、健康相关生活质量和身体成分等。将进行定性访谈，以了解患者对试验参与和干预参与及依从性的体验和态度。
CARE 将评估在结直肠癌手术前进行强化有目的减肥作为预康复的可行性。结果将决定确定性试验的规划。
