The Effects and Mechanisms of Short-Term Nutritional Enhancement Combined With Health Education on Clinical Outcomes in Postoperative Patients With Colorectal Cancer: A Multicenter, Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA)
研究概览
简要总结
This clinical study aims to evaluate whether short-term personalized nutritional support, when combined with structured health education, can improve nutritional status, quality of life, and clinical outcomes in patients who have undergone surgery for colorectal cancer (CRC). Colorectal cancer is one of the most common cancers worldwide, and many patients experience malnutrition and poor physical condition during treatment, which can negatively affect recovery and long-term survival.
In this multicenter, randomized, controlled clinical trial, approximately 360 postoperative CRC patients will be enrolled and randomly assigned to one of four groups: (A) nutritional enhancement combined with health education, (B) health education alone, (C) nutritional enhancement alone, or (D) standard care (control group). Nutritional support will include individualized diet counseling and oral nutritional supplements tailored to each patient's needs. Health education will be delivered using an "Internet Plus" approach, including weekly educational videos and expert consultations focusing on nutrition, physical activity, and mental health.
The primary objectives are to determine whether these interventions can improve patients' short-term nutritional status and quality of life. Secondary outcomes include the impact of interventions on long-term survival, treatment-related side effects, patient adherence to nutrition recommendations, and psychological well-being.
This study will also investigate the biological mechanisms underlying the clinical effects by analyzing changes in the gut microbiome, blood-based metabolic profiles, and immune responses. Blood, stool, and tumor tissue samples will be collected and analyzed using advanced techniques, including untargeted metabolomics, metagenomics, and single-cell sequencing.
This trial is designed to provide evidence for the integration of nutritional strategies into routine cancer care, and to guide the development of more personalized, effective nutrition-based therapies for colorectal cancer patients. Participants will be followed for up to annually up to 5 years to evaluate both clinical outcomes and biological markers of response.
详细描述
This is a prospective, multicenter, open-label, randomized controlled clinical trial designed to assess the effects and underlying mechanisms of short-term nutritional enhancement combined with health education on clinical outcomes in patients undergoing surgery for non-metastatic colorectal cancer (stages IIa, IIb, IIIa). The rationale is based on the high prevalence of malnutrition among CRC patients, which significantly impacts treatment tolerance, quality of life, and long-term prognosis.
Eligible participants will be randomized into four parallel arms: (1) individualized nutritional enhancement plus structured health education; (2) structured health education alone; (3) individualized nutritional enhancement alone; and (4) standard care without additional intervention. Personalized nutrition plans will be developed based on energy and protein needs, supported by dietary counseling and the provision of oral nutritional supplements. Health education will be delivered through a digital platform, featuring weekly videos and interactive content on nutrition, exercise, and psychological well-being.
The study includes a 14-day intervention phase and a 12-month follow-up period. Outcomes will be assessed at baseline, and at 1, 2, 3, 6, and 12 months, and annually up to 5 years to evaluate both clinical outcomes and biological markers of response.post-intervention. Key endpoints include improvements in nutritional status, patient-reported quality of life, and overall survival metrics.
To investigate mechanisms, the study incorporates biological sampling and multi-omics analysis. Non-targeted serum metabolomics, gut microbiota metagenomics, and single-cell RNA sequencing of tumor and adjacent normal tissues will be used to characterize metabolic and immune changes associated with the interventions. The study also evaluates the role of inflammatory markers and immune cell profiles in mediating clinical effects.
This trial is expected to generate high-quality evidence supporting the integration of nutrition and health education strategies into standard postoperative care for CRC patients. It may also identify novel metabolic or microbial biomarkers associated with treatment response and prognosis, contributing to the development of precision nutrition approaches in oncology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Laboratory personnel conducting metabolomic, microbiome, and single-cell analyses will remain blinded to group allocation to reduce bias during data generation and interpretation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age ≥ 18 years
- •Pathologically confirmed diagnosis of colon or rectal cancer
- •Mentally alert and capable of communication
- •Willing to participate in follow-up, with an estimated life expectancy of more than 6 months
- •Cancer stage IIa, IIb, or IIIa
排除标准
- •Nutritional risk screening score of mPG-SGA < 2 or NRS-2002 < 3
- •Diagnosed with AIDS
- •History of organ transplantation
- •Pregnant or breastfeeding women
- •Concurrent participation in another interventional clinical trial
- •Inability to care for oneself independently
- •Inability to engage in physical activity during the perioperative period
- •Severe comorbid conditions (e.g., uncontrolled cardiovascular disease, severe hepatic or renal dysfunction)
- •Known allergy or intolerance to components of the nutritional supplements used in the study
研究组 & 干预措施
Nutritional Enhancement Plus Health Education
Participants in this arm will receive individualized nutritional enhancement along with structured health education. Nutritional intervention includes personalized dietary plans and oral nutritional supplements based on energy and protein requirements. Health education is delivered via an "Internet Plus" platform and includes weekly videos and interactive content focusing on nutrition, physical activity, and psychological support. The intervention lasts for 14 days and is followed by a 12-month, and annually up to 5 years to evaluate both clinical outcomes and biological markers of response. follow-up period.
干预措施: Structured Nutrition-Focused Health Education (Behavioral)
Nutritional Enhancement Only
Participants in this arm will receive individualized nutritional enhancement based on personalized dietary assessment and calculated energy and protein needs. Interventions include oral nutritional supplements and tailored dietary counseling provided by a clinical nutrition team. No additional health education is provided. The intervention phase lasts for 14 days, with scheduled follow-up for 12 months and annually up to 5 years.
干预措施: Personalized Parenteral Nutritional Supplementation (Drug)
Nutritional Enhancement Plus Health Education
Participants in this arm will receive individualized nutritional enhancement along with structured health education. Nutritional intervention includes personalized dietary plans and oral nutritional supplements based on energy and protein requirements. Health education is delivered via an "Internet Plus" platform and includes weekly videos and interactive content focusing on nutrition, physical activity, and psychological support. The intervention lasts for 14 days and is followed by a 12-month, and annually up to 5 years to evaluate both clinical outcomes and biological markers of response. follow-up period.
干预措施: Personalized Oral Nutritional Supplementation (Dietary Supplement)
Health Education Only
Participants in this arm will receive structured health education without additional nutritional supplementation. The education is delivered via an "Internet Plus" platform, including weekly videos and interactive content focused on nutrition knowledge, physical activity guidance, and psychological support. This intervention is administered for 14 days, followed by a 12-month follow-up and annually up to 5 years.
干预措施: Structured Nutrition-Focused Health Education (Behavioral)
Nutritional Enhancement Only
Participants in this arm will receive individualized nutritional enhancement based on personalized dietary assessment and calculated energy and protein needs. Interventions include oral nutritional supplements and tailored dietary counseling provided by a clinical nutrition team. No additional health education is provided. The intervention phase lasts for 14 days, with scheduled follow-up for 12 months and annually up to 5 years.
干预措施: Personalized Oral Nutritional Supplementation (Dietary Supplement)
Nutritional Enhancement Plus Health Education
Participants in this arm will receive individualized nutritional enhancement along with structured health education. Nutritional intervention includes personalized dietary plans and oral nutritional supplements based on energy and protein requirements. Health education is delivered via an "Internet Plus" platform and includes weekly videos and interactive content focusing on nutrition, physical activity, and psychological support. The intervention lasts for 14 days and is followed by a 12-month, and annually up to 5 years to evaluate both clinical outcomes and biological markers of response. follow-up period.
干预措施: Personalized Parenteral Nutritional Supplementation (Drug)
结局指标
主要结局
Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA)
时间窗: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Longitudinal assessment of nutritional status using the mPG-SGA, a validated tool composed of five sections (weight loss history, dietary intake, symptoms, function/activity, and age). Total scores range from 0 to ≥7 points, with higher scores indicating worse nutritional status. Patients will be classified as: 0-2 = Normal 3-6 = Mild malnutrition ≥7 = Moderate to severe malnutrition.
Change in Global Health Status Score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
时间窗: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Assessment of patients' perceived overall health status using the global health subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores range from 0 to 100, with higher scores indicating better global quality of life.
Change in Symptom Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
时间窗: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Assessment of symptom burden including fatigue, pain, nausea/vomiting, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulty using symptom subscales of the EORTC QLQ-C30. Each symptom is scored separately from 0 to 100, with higher scores indicating worse symptom severity.
Overall Survival (OS) in Cancer Patients
时间窗: From date of enrollment until death or last follow-up (up to 5 years)
Overall survival is defined as the time from the date of enrollment to the date of death from any cause. Patients still alive at the last follow-up will be censored. Kaplan-Meier survival analysis and Cox proportional hazards regression will be used to estimate survival and explore associations with baseline and longitudinal nutritional status.
Progression-Free Survival (PFS) in Cancer Patients
时间窗: From date of enrollment until death or last follow-up (up to 5 years)
Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first. Patients without progression at the time of last follow-up will be censored. PFS will be analyzed using Kaplan-Meier estimates and Cox regression models, stratified by nutritional status.
次要结局
- Change in Nutritional Risk Assessed by Nutritional Risk Screening 2002 (NRS-2002)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Serum Total Protein(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Serum Albumin(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Serum Prealbumin(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Serum Transferrin(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- C-Reactive Protein (CRP)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Blood Glucose(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Aspartate Aminotransferase (AST)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Alanine Aminotransferase (ALT)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Interleukin-1 (IL-1)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Tumor Necrosis Factor-alpha (TNF-α)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Serum Creatinine(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Blood Urea Nitrogen(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Total Bilirubin(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Total Cholesterol(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Triglycerides(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- High-Density Lipoprotein Cholesterol (HDL-C)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Interleukin-6 (IL-6)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Hemoglobin(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- White Blood Cell Count (Leukocytes)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Neutrophil Count(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Lymphocyte Count(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Red Blood Cell Count(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Platelet Count(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Height(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Body Weight(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Body Mass Index (BMI)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Change in Anxiety Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-A)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Change in Depression Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-D)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Functional Performance Measured by Karnofsky Performance Status (KPS)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Changes in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Changes in Physical Activity Level During Cancer Treatment(Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years)
- Changes in Nutrition-Related Knowledge, Attitudes, and Practices (KAP)(Baseline, after the intervention, 6 months after intervention; annually up to 5 years)
- Healthcare Utilization and Cost of Nutrition-Related Care(From admission through 30-day post-discharge and annually for 5 years)
- Incidence of Serious Adverse Events Related to Nutrition or Treatment(Continuously from enrollment through end of study follow-up (up to 5 years))
研究者
Xiaoqin Luo
Professor
Xi'an Jiaotong University