Epidemiology and risk factors of colorectal cancer in China.
Yong Yang, Zihan Han, Xin Li...
https://pubmed.ncbi.nlm.nih.gov/33446996Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07087561
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
Led by Xiaoqin Luo · Updated on 2025-07-28
360
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether short-term personalized nutritional support combined with structured health education can improve nutritional status, quality of life, and clinical outcomes in patients who have undergone surgery for colorectal cancer. This trial focuses on patients with non-metastatic colorectal cancer stages IIa, IIb, and IIIa, addressing the common problem of malnutrition and poor physical condition during treatment that may affect recovery and survival. Participants are randomly assigned to one of four groups: nutritional enhancement plus health education, health education alone, nutritional enhancement alone, or standard care without these interventions. Nutritional support includes personalized dietary counseling and oral or parenteral nutritional supplements tailored to individual energy and protein needs. Health education is delivered digitally via an "Internet Plus" platform with weekly videos and expert guidance, focusing on nutrition, exercise, and psychological well-being. The intervention phase lasts 14 days, followed by a 12-month follow-up and annual assessments up to 5 years. During the study, participants undergo assessments of nutritional status, quality of life, symptom scores, and survival at multiple time points including baseline, post-intervention, and several months afterward. Biological samples such as blood, stool, and tumor tissue are collected for analysis of metabolic, immune, and microbiome changes. Researchers also monitor treatment side effects, patient adherence, psychological health, and healthcare utilization. This comprehensive follow-up up to 5 years aims to provide evidence for integrating nutrition and health education into colorectal cancer care and to uncover biological mechanisms behind treatment effects.
CONDITIONS
Brief 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
You may qualify if you...
- Signed informed consent
- Age 65 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 14 days
Participants receive short-term nutritional enhancement and/or structured health education for 14 days after surgery. Nutritional enhancement includes personalized oral or parenteral supplements tailored to individual energy and protein needs. Health education is delivered via a digital platform with weekly videos and interactive content focusing on nutrition, exercise, and psychological well-being.
Regular assessments and adjustments every 3 days during the 14-day intervention
Follow-up
Duration - 12 months and annually up to 5 years
Participants are followed for 12 months and annually up to 5 years to monitor clinical outcomes, nutritional status, quality of life, and survival. Biological samples and health assessments are collected during this period to evaluate long-term effects and mechanisms of the interventions.
Visits at baseline, after intervention, 1, 2, 3, 6, and 12 months; annual visits thereafter up to 5 years
Trial Site Locations
Total: 1 location
1
Xi 'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Actively Recruiting
Loading map...
Research Team
X
Xiaoqin Luo, Ph.D
H
Hexiang Yang, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Comparing Video-Based, Telehealth-Delivered Exercise and Weight Loss Programs With Online Education on Outcomes of Knee Osteoarthritis : A Randomized Trial.
Kim L Bennell, Belinda J Lawford, Catherine Keating...
https://pubmed.ncbi.nlm.nih.gov/34843383Video-based health education to support insulin therapy in diabetes mellitus patients.
Dinda M N Ratri, Khusnul Fitri Hamidah, Arina D Puspitasari...
https://pubmed.ncbi.nlm.nih.gov/32728588Massive open online nutrition and cooking course for improved eating behaviors and meal composition.
Maya Adam, Kelly C Young-Wolff, Ellen Konar...
https://pubmed.ncbi.nlm.nih.gov/26630879Identification of Novel Tumor-Microenvironment-Regulating Factor That Facilitates Tumor Immune Infiltration in Colon Cancer.
Ying Wang, Yu Wang, Caihua Xu...
https://pubmed.ncbi.nlm.nih.gov/33230430Randomised controlled trial of early prophylactic feeding vs standard care in patients with head and neck cancer.
Teresa E Brown, Merrilyn D Banks, Brett G M Hughes...
https://pubmed.ncbi.nlm.nih.gov/28535154The provision of nutritional advice and care for cancer patients: a UK national survey of healthcare professionals.
Jane L Murphy, Fehmidah Munir, Fiona Davey...
https://pubmed.ncbi.nlm.nih.gov/32918612Quantification of Serum Metabolites in Early Colorectal Adenomas Using Isobaric Labeling Mass Spectrometry.
Yuan Liu, Hua Zhang, William F Dove...
https://pubmed.ncbi.nlm.nih.gov/37014956Microbial metabolites in colorectal tumorigenesis and cancer therapy.
Yali Liu, Harry Cheuk-Hay Lau, Jun Yu
https://pubmed.ncbi.nlm.nih.gov/37095682Microbial Metabolite Dysbiosis and Colorectal Cancer.
Patrick Niekamp, Chang H Kim
https://pubmed.ncbi.nlm.nih.gov/36632785