Short-Term Nutritional Enhancement Combined With Health Education in Postoperative Colorectal Cancer Patients: A Randomized Controlled Trial

Browse trials for

• Colorectal Neoplasms 5,599
• Disease 1,327
• Malnutrition 1,587
• Health Education 184

Keywords

• Colorectal Cancer
• Nutrition Support
• Health Education
• Patient-Reported Outcomes
• Nutritional Risk
• Cancer Rehabilitation
• Randomized Controlled Trial

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 360 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Lead sponsor

Xiaoqin Luo is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  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.

  Dietary Supplement: Personalized Oral Nutritional Supplementation · Drug: Personalized Parenteral Nutritional Supplementation · Behavioral: Structured Nutrition-Focused Health Education

• Experimental
  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.

  Behavioral: Structured Nutrition-Focused Health Education

• Experimental
  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.

  Dietary Supplement: Personalized Oral Nutritional Supplementation · Drug: Personalized Parenteral Nutritional Supplementation

• No intervention
  Standard Care (Control)

  Participants in this arm will receive standard inpatient care without structured nutritional intervention or health education. Patients eat according to personal ability and appetite but do not receive individualized nutrition counseling or supplemental nutrition support. This group serves as the control group for comparison. Routine clinical follow-up will be conducted for 12 months and annually up to 5 years.

Interventions

• Dietary supplementPersonalized Oral Nutritional Supplementation

  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.

  Also known as: ONS

• DrugPersonalized Parenteral Nutritional Supplementation

  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.

  Also known as: PN

• BehavioralStructured Nutrition-Focused Health Education

  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.

  Also known as: Internet-Based Health Education, Multimedia Health Literacy Intervention

Primary outcomes

1. Change 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

2. 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

3. 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

4. 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)

5. 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)

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. Blood Glucose

   Fasting blood glucose (mmol/L), measured to assess metabolic function and risk of hyperglycemia.

   Time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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)

Other outcomes

1. Predictive Value of Baseline Nutritional Indicators for 30-Day Clinical Events

   Evaluation of whether baseline nutritional indicators-including mPG-SGA scores and laboratory biomarkers such as albumin, prealbumin, and CRP-predict 30-day clinical outcomes, including mortality, ICU admission, and significant unintentional weight loss (\>5%). Logistic regression will be used for model construction and discrimination.

   Time frame: Baseline to 30 days post-admission

2. Nutritional Trajectory Typing and Clustering

   Identification of distinct nutritional change trajectories over time using latent class growth analysis (LCGA) and hierarchical clustering based on serial measurements of mPG-SGA and anthropometric data. Trajectories will be used to classify patients into nutritional risk subgroups.

   Time frame: From baseline to 12-month follow-up

3. Agreement Between Nutritional Screening Tools (mPG-SGA vs. NRS-2002)

   Assessment of the diagnostic agreement, sensitivity, and specificity of two nutritional screening tools-modified Patient-Generated Subjective Global Assessment (mPG-SGA) and Nutritional Risk Screening 2002 (NRS-2002)-in detecting malnutrition risk. Agreement will be evaluated using Cohen's kappa and ROC curve analysis.

   Time frame: Baseline and each scheduled follow-up (up to 5 years)

4. Sociodemographic Determinants of Malnutrition

   Analysis of sociodemographic factors-including income level, education, employment status, and rural vs. urban residence-in predicting baseline malnutrition and nutritional deterioration over time. Multivariable models will be used to explore independent associations.

   Time frame: From baseline throughout study follow-up (up to 5 years)

5. Patient Adherence to Out-of-Hospital Nutritional Support

   Evaluation of patient-reported adherence to prescribed oral nutritional supplements or enteral/parenteral support regimens after hospital discharge. Adherence data will be collected via structured interviews and compared with clinical outcomes and readmission rates.

   Time frame: Baseline to 12 months post-treatment initiation

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• Morgan E, Arnold M, Gini A, Lorenzoni V, Cabasag CJ, Laversanne M, Vignat J, Ferlay J, Murphy N, Bray F. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Gut. 2023 Feb;72(2):338-344. doi: 10.1136/gutjnl-2022-327736. Epub 2022 Sep 8. PubMed 36604116 ↗
• Zheng R, Zhang S, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2016. J Natl Cancer Cent. 2022 Feb 27;2(1):1-9. doi: 10.1016/j.jncc.2022.02.002. eCollection 2022 Mar. PubMed 39035212 ↗
• Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108. PubMed 35143424 ↗
• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PubMed 33538338 ↗

Related links

• World Health Organization. Cancer\[EB/OL\]. Cancer\[2023-05-12\]. ↗
• World Health Organization. Colorectal Cancer Awareness Month 2022 ↗

Study documents

• Protocol and statistical analysis plan · Oct 10, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The study intends to share IPD with other researchers for advancing scientific understanding and improving patient care. The shared data will include anonymized participant information, such as demographic details, clinical outcomes, and treatment responses. The data will be stripped of any identifiers to ensure participant confidentiality.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code