[Effect of an oral nutritional supplementation on nutritional status and quality of life in patients with colorectal cancer and postoperative adjuvant chemotherapy: A multi-center prospective randomized control trial]

Objective: To evaluate the effect of oral nutritional supplementation (ONS) on the nutritional status and quality of life in patients with colorectal cancer and postoperative adjuvant chemotherapy. Methods: This study was registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-13003798). A multi-center randomized controlled trial was conducted. Colorectal cancer patients who underwent radical surgery and postoperative adjuvant chemotherapy, and had nutritional risk (nutrition risk screening 2002 score ≥3) when discharge from hospital in six hospitals (Beijing Hospital, Peking University Third Hospital, Guangzhou Nanfang Hospital, Shanghai Xinhua Hospital, Shanghai Ruijin Hospital, and Shanghai The Sixth People's Hospital) from June 2013 to August 2015 were prospectively enrolled. These patients were randomly divided into the ONS group and control group. Patients in the ONS group received dietary guidance and oral nutritional supplements (2092 kJ/day, whole protein enteral nutrition) for 90 days after discharge from hospital, while patients in the control group only received dietary guidance. Anthropometric measurements (body weight, body mass index [BMI], upper arm circumference, gripping power of the dominant hand, triceps skin fold), nutrition-related laboratory tests (hemoglobin, albumin, prealbumin, total cholesterol, triglyceride), gastrointestinal function scores and quality of life (evaluated by EuroQol five dimensions questionnaire) were collected and compared at baseline (at discharge), and at 30-day, 60-day and 90-day after discharge. Results: A total of 90 patients were included into this multi-center study, of whom 5 patients dropped out, 43 patients were assigned to the ONS group and 42 patients to the control group. Compared with baseline, the body weight of patients in the ONS group increased by (1.523±0.525) kg at 60-day and (1.967±0.661) kg at 90-day, which were significantly higher than those of patients in the control group [60-day: (-0.325±0.518) kg, P=0.015; 90-day: (-0.224±0.705) kg, P=0.027, respectively]. A similar pattern was observed for BMI, the ONS group increased by (0.552±0.203) kg/m(2) at 60-day and (0.765±0.205) kg/m(2) at 90-day, which were significantly higher than those of patients in control group [60-day: (-0.067±0.202) kg/m(2), P=0.034; 90-day: (0.022±0.210) kg/m(2), P=0.013]. No significant differences of other anthropometric measurements and nutrition-related laboratory tests were found between the two groups (all P>0.05). Furthermore, there were no significant differences of improvement in gastrointestinal function and quality of life between two groups (all P>0.05). Conclusion: Oral nutritional supplements can improve the body weight and BMI of colorectal cancer patients with nutritional risk receiving postoperative adjuvant chemotherapy, though it does not improve the quality of life.

目的： 评价口服营养补充疗法（ONS）对结直肠癌术后辅助化疗患者营养状态及生活质量的影响。 方法： 采用多中心随机对照试验。前瞻性入组2013年6月至2015年8月间在六家医疗中心（北京医院；北京大学第三医院；上海交通大学医学院附属瑞金医院、附属新华医院和附属第六医院；南方医科大学附属南方医院）接受根治性手术加术后辅助化疗、且出院时存在营养风险（营养风险筛查NRS 2002评分≥3分）的结直肠癌患者，通过随机数字表法将研究对象分为ONS组和对照组。ONS组除饮食指导外，每日给予口服营养补充疗法（整蛋白肠内营养制剂，500 kcal/d，餐间分次口服），自出院第一天开始，连续90 d；对照组仅给予饮食指导。观察出院后30、60和90 d患者人体测量指标（体质量、体质指数、上臂围、利手握力和三头肌皮褶厚度）、营养相关实验室检查（血红蛋白、白蛋白、前白蛋白、甘油三酯和总胆固醇）、胃肠道功能状态评分及生活质量评分的变化（以出院时检查结果作为基线）。 结果： 90例结直肠癌患者符合入选标准进入研究，最终85例完成研究，其中ONS组43例，对照组42例。研究组出院后60 d体质量增加（1.523±0.525）kg，90 d体质量增加（1.967±0.661）kg，与对照组[60 d：（-0.325±0.518）kg；90 d：（-0.224±0.705）kg]比较，差异有统计学意义（P=0.015；P=0.027）。ONS组60 d体质指数增加（0.552±0.203）kg/m(2)，90 d增加（0.765±0.205）kg/m(2)，与对照组[60 d：（-0.067±0.202）kg/m(2)；90 d：（0.022±0.210）kg/m(2)]比较，差异有统计学意义（P=0.034；P=0.013）。其他人体测量指标和营养相关实验室指标的变化值两组差异均无统计学意义（均P>0.05）。出院后胃肠功能状态评分和生活质量评分的变化值两组差异亦无统计学意义（均P>0.05）。 结论： 对于存在营养风险的结直肠癌术后患者，出院后予以口服营养补充疗法可显著改善其体质量和体质指数，但患者的生活质量并未获益。.

Keywords: Adjuvant chemotherapy; Body mass index; Colorectal neoplasms; Oral nutritional supplements; Quality of life.