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

NCT07087561 | Recruiting DMC

• 1 other identifier: No: XJTU1AF2025LSYY-016
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer (Diagnosis); Malnutrition or Risk of Malnutrition

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  From date of enrollment until death or last follow-up (up to 5 years)

Secondary Outcomes (36)

• 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

Other Outcomes (5)

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

  Baseline to 30 days post-admission

• Nutritional Trajectory Typing and Clustering

  From baseline to 12-month follow-up

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

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

Study Arms (4)

Nutritional Enhancement Plus Health Education

EXPERIMENTAL

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

Health Education Only

EXPERIMENTAL

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

Nutritional Enhancement Only

EXPERIMENTAL

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

Standard Care (Control)

NO INTERVENTION

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

Personalized Oral Nutritional Supplementation DIETARY_SUPPLEMENT

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

Nutritional Enhancement Only; Nutritional Enhancement Plus Health Education

Personalized Parenteral Nutritional Supplementation DRUG

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

Nutritional Enhancement Only; Nutritional Enhancement Plus Health Education

Structured Nutrition-Focused Health Education BEHAVIORAL

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

Health Education Only; Nutritional Enhancement Plus Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiaoqin Luo: lead

Study Sites (1)

Xi 'an Jiaotong University

Xi'an, Shaanxi, 710000, China

RECRUITING

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Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms; Disease; Malnutrition; Health Education

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Xiaoqin Luo, Ph.D

CONTACT

+8618802932796; luoxiaoqin2012@xjtu.edu.cn

Hexiang Yang, Ph.D

CONTACT

+8617791547192; clyeah@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Laboratory personnel conducting metabolomic, microbiome, and single-cell analyses will remain blinded to group allocation to reduce bias during data generation and interpretation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is a prospective, multicenter, open-label, parallel-group randomized controlled trial involving four intervention arms. Participants are assigned in a 1:1:1:1 ratio to one of the following: (A) short-term nutritional enhancement combined with health education, (B) health education alone, (C) nutritional enhancement alone, or (D) standard care. Stratified randomization is performed based on baseline nutritional status and cancer stage to ensure group balance.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 28, 2025
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 10, 2029
• Study Completion (Estimated): October 10, 2030
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available after the publication of the main study results, anticipated to be by the end of 2030. The data will be accessible for a period of five years following this date.
• Access Criteria: Researchers interested in accessing the data will be required to submit a proposal outlining their intended use of the data, which will be reviewed by the study's principal investigator. Access will be granted based on the scientific merit and ethical considerations of the proposal.

Locations

CN (1)