Division of Nutrition & Dietetics, School of Health Sciences, International Medical University, 50700 Bukit Jalil, Kuala Lumpur, Malaysia.
Department of Surgery, School of Medicine, International Medical University, Jalan Rasah, 70300, Seremban, Negeri Sembilan, Malaysia.
Trials. 2021 Nov 3;22(1):767. doi: 10.1186/s13063-021-05716-5.
While it is well established that perioperative use of oral nutrition supplement (ONS) improves nutrition status among severely malnourished surgical cancer patients, the evidence requires further substantiation for non-severely malnourished patients with cancer. This protocol paper presents the rationale and design of a randomised controlled trial to evaluate the effectiveness of preoperative as well as an extended 90-day postoperative use of ONS on nutritional and clinical outcomes among patients undergoing elective surgery for breast and colorectal cancer.
Patients with primary breast and colorectal cancer undergoing elective surgery are recruited from two tertiary hospitals. Eligible patients are assigned into one of the three intervention arms: (i) Group SS will receive ONS in addition to their normal diet up to 14 days preoperatively and postoperatively up to discharge; (ii) Group SS-E will receive ONS in addition to their normal diet up to 14 days preoperatively, postoperatively up to discharge and for an extended 90 days after discharge; and (iii) Group DS will receive ONS in addition to their normal diet postoperatively up to discharge from the hospital. The ONS is a standard formula fortified with lactium to aid in sleep for recovery. The primary endpoints include changes in weight, body mass index (BMI), serum albumin and prealbumin levels, while secondary endpoints are body composition (muscle and fat mass), muscle strength (handgrip strength), energy and protein intake, sleep quality, haemoglobin, inflammatory markers (transferrin, high sensitivity C-reactive protein, interleukin-6), stress marker (saliva cortisol), length of hospital stay and postoperative complication rate.
This trial is expected to provide evidence on whether perioperative supplementation in breast and colorectal cancer patients presenting with high BMI and not severely malnourished but undergoing the stress of surgery would be beneficial in terms of nutritional and clinical outcomes.
ClinicalTrial.gov NCT04400552. Registered on 22 May 2020, retrospectively registered.
虽然围手术期使用口服营养补充剂（ONS）可改善严重营养不良的外科癌症患者的营养状况，但对于非严重营养不良的癌症患者，这一证据仍需要进一步证实。本研究方案旨在报告一项随机对照试验的原理和设计，该试验旨在评估术前及术后 90 天延长ONS 对择期行乳腺癌和结直肠癌手术患者的营养和临床结局的有效性。
从两家三级医院招募接受择期手术的原发性乳腺癌和结直肠癌患者。符合条件的患者被分配到以下三个干预组之一：（i）SS 组将在术前 14 天及术后至出院期间接受 ONS 治疗；（ii）SS-E 组将在术前 14 天及术后至出院期间及出院后 90 天延长ONS 治疗；（iii）DS 组将在术后至出院期间接受 ONS 治疗。ONS 是一种标准配方，添加了 lactium，有助于恢复睡眠。主要终点包括体重、体重指数（BMI）、血清白蛋白和前白蛋白水平的变化，次要终点包括身体成分（肌肉和脂肪量）、肌肉力量（手握力）、能量和蛋白质摄入、睡眠质量、血红蛋白、炎症标志物（转铁蛋白、高敏 C 反应蛋白、白细胞介素-6）、应激标志物（唾液皮质醇）、住院时间和术后并发症发生率。
本试验有望提供证据，证明对于 BMI 较高、但没有严重营养不良且正在接受手术应激的乳腺癌和结直肠癌患者，围手术期补充ONS 是否有益于营养和临床结局。
ClinicalTrials.gov NCT04400552. 2020 年 5 月 22 日注册，回顾性注册。
