Clinical trial · Interventional
Short-Term Nutritional Enhancement Combined With Health Education in Postoperative Colorectal Cancer Patients: A Randomized Controlled Trial
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (Diagnosis) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Malnutrition or Risk of Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized Oral Nutritional Supplementation | Dietary Supplement | — | UNRESOLVED |
| Personalized Parenteral Nutritional Supplementation | Drug | — | UNRESOLVED |
| Structured Nutrition-Focused Health Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Nutritional Enhancement Plus Health Education
- description
- 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.
- interventionNames
- Dietary Supplement: Personalized Oral Nutritional Supplementation
- Drug: Personalized Parenteral Nutritional Supplementation
- Behavioral: Structured Nutrition-Focused Health Education
- type
- EXPERIMENTAL
- label
- Health Education Only
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (40)
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