Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07087561

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

Led by Xiaoqin Luo · Updated on 2025-07-28

360

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Age 18 years or older
  • 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 greater than 6 months
  • Cancer stage IIa, IIb, or IIIa
Not Eligible

You will not qualify if you...

  • Nutritional risk screening score of mPG-SGA less than 2 or NRS-2002 less than 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 such as uncontrolled cardiovascular disease or severe liver or kidney dysfunction
  • Known allergy or intolerance to components of the nutritional supplements used in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Xi 'an Jiaotong University

Xi'an, Shaanxi, China, 710000

Actively Recruiting

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Research Team

X

Xiaoqin Luo, Ph.D

CONTACT

H

Hexiang Yang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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