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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
360
Participants receive individualized oral nutritional supplementation based on energy and protein requirements, calculated using the Harris-Benedict equation and body weight (1.2-1.5 g protein/kg/day). The supplement may include complete nutrition powder, whey protein powder, and compound multivitamins. The intervention is prescribed and monitored by a clinical nutrition team and adjusted every 3 days during the 14-day intervention phase. The goal is to ensure both energy and protein intake targets are met. Supplements are administered in addition to standard meals.
For participants unable to meet nutritional goals through oral intake, parenteral nutrition is administered intravenously. The formulation includes amino acids, glucose, lipids, electrolytes, trace elements, and vitamins. Dosages are aligned with those of the enteral nutrition group, ensuring a consistent intake of energy and protein (1.2-1.5 g/kg/day protein). Formulation and administration follow standardized hospital protocols and are supervised by the nutrition support team.
Participants receive structured health education focused on nutrition, physical activity, and psychological well-being. The education is delivered over 14 days using a digital "Internet Plus" platform, featuring weekly videos, interactive Q\&A sessions, and guidance from a multidisciplinary nutrition support team. Educational content covers dietary recommendations, exercise safety, stress management, and post-treatment recovery strategies. Materials are updated weekly, and participants may access them remotely via smartphone or tablet. This intervention aims to improve nutrition knowledge, adherence, and health behavior change.
Xi 'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGChange in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA)
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.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Change in Global Health Status Score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Change in Symptom Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Overall Survival (OS) in Cancer Patients
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.
Time frame: From date of enrollment until death or last follow-up (up to 5 years)
Progression-Free Survival (PFS) in Cancer Patients
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.
Time frame: From date of enrollment until death or last follow-up (up to 5 years)
Change in Nutritional Risk Assessed by Nutritional Risk Screening 2002 (NRS-2002)
Longitudinal evaluation of nutritional risk using the NRS-2002, which considers disease severity, nutritional impairment, and age. Total score ranges from 0 to ≥7 points. A score of ≥3 indicates nutritional risk and warrants intervention; \<3 indicates no immediate risk.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Serum Total Protein
Serum total protein concentration (g/L), used to evaluate protein-energy nutritional status. Measured using standard biochemical assays.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Serum Albumin
Serum albumin concentration (g/L), used to assess visceral protein status and systemic inflammation.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Serum Prealbumin
Serum prealbumin level (mg/L), an indicator of short-term changes in protein-energy nutritional status.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Serum Transferrin
Serum transferrin concentration (g/L), a marker of protein status and iron metabolism.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
C-Reactive Protein (CRP)
Serum CRP (mg/L), a marker of systemic inflammation and acute-phase response.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Blood Glucose
Fasting blood glucose (mmol/L), measured to assess metabolic function and risk of hyperglycemia.
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Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Aspartate Aminotransferase (AST)
AST concentration (U/L), used as a liver function test and hepatotoxicity marker.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Alanine Aminotransferase (ALT)
ALT level (U/L), a liver enzyme measured to monitor hepatic injury.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Interleukin-1 (IL-1)
IL-1 concentration (pg/mL), a pro-inflammatory cytokine indicative of immune and inflammatory activity.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Tumor Necrosis Factor-alpha (TNF-α)
Tumor Necrosis Factor-alpha (TNF-α) level (pg/mL) measured to assess systemic inflammation and cancer-related cachexia.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Serum Creatinine
Serum creatinine (μmol/L), measured to evaluate kidney function and treatment-related nephrotoxicity.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Blood Urea Nitrogen
Blood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Total Bilirubin
Blood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Total Cholesterol
Total cholesterol level (mmol/L), measured to assess lipid metabolism and nutritional status.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Triglycerides
Serum triglyceride level (mmol/L), used to evaluate energy reserves and lipid metabolism.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
High-Density Lipoprotein Cholesterol (HDL-C)
HDL-C (mmol/L), assessed as a marker of cardiovascular health and lipid status.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Low-Density Lipoprotein Cholesterol (LDL-C)
LDL-C (mmol/L), measured as a risk factor for cardiovascular disease and lipid status.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Interleukin-6 (IL-6)
IL-6 level (pg/mL), a pro-inflammatory cytokine measured to monitor systemic inflammation and cachexia.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Hemoglobin
Hemoglobin concentration (\*10⁹/L), used to assess anemia and oxygen-carrying capacity.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
White Blood Cell Count (Leukocytes)
Total white blood cell count (\*10⁹/L), measured to monitor immune status and detect infection or myelosuppression.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Neutrophil Count
Absolute neutrophil count (\*10⁹/L), used to assess infection risk and bone marrow suppression.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Lymphocyte Count
Lymphocyte count (\*10⁹/L), measured to evaluate immune competence.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Red Blood Cell Count
Red blood cell count (\*10¹²/L), used to assess erythropoiesis and anemia.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Platelet Count
Platelet count (\*10⁹/L), measured to evaluate coagulation status and myelosuppression.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Height
Standing height (cm) measured using a stadiometer with 0.5 cm precision. Values adjusted for presence of ascites, edema, or large tumors.ascites, systemic edema, and huge tumors.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Body Weight
Body weight (kg) measured using a calibrated scale with 0.2 kg precision. Values adjusted if ascites or edema are present.
Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years
Body Mass Index (BMI)
BMI calculated as weight (kg) divided by height squared (m²), recorded to one decimal place.
Time frame: 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)
Assessment of anxiety using the HADS-A subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Results will be analyzed in relation to nutritional status (normal, mild, moderate malnutrition).
Time frame: 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)
Assessment of depressive symptoms using the HADS-D subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe depression. Results will be analyzed in relation to nutritional status (normal, mild, moderate malnutrition).
Time frame: 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)
Functional performance will be evaluated using the Karnofsky Performance Status (KPS) scale, which ranges from 0 to 100. Higher scores indicate better functional ability and independence in daily activities. Longitudinal KPS changes will be assessed in relation to changes in nutritional status over time.
Time frame: 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)
Sleep quality and disturbances will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a standardized questionnaire assessing seven components of sleep. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. PSQI scores will be analyzed in relation to nutritional risk categories and treatment phases.
Time frame: 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
Assessment of leisure-time physical activity levels (mild, moderate, vigorous) and their relationship with nutritional status and cancer treatment response.
Time frame: 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)
Patients' dietary knowledge, attitudes, and practices will be assessed using a validated Nutrition KAP (Knowledge, Attitude, and Practice) questionnaire. The total score ranges from 0 to 104, with higher scores indicating better nutritional knowledge, more positive attitudes, and healthier dietary behaviors. Longitudinal changes in KAP scores will be evaluated in relation to treatment outcomes.
Time frame: Baseline, after the intervention, 6 months after intervention; annually up to 5 years
Healthcare Utilization and Cost of Nutrition-Related Care
Evaluation of healthcare utilization related to nutritional care, including total number of hospitalization days, number of ICU admissions, and direct costs associated with enteral and parenteral nutrition support. Metrics will be analyzed in relation to malnutrition risk at baseline and during treatment.
Time frame: From admission through 30-day post-discharge and annually for 5 years
Incidence of Serious Adverse Events Related to Nutrition or Treatment
Tracking of serious adverse events potentially related to nutritional support or treatment, including infections, allergic reactions, gastrointestinal distress, and metabolic complications.
Time frame: Continuously from enrollment through end of study follow-up (up to 5 years)