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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Xi 'an Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Xiaoqin Luo, Ph.D
luoxiaoqin2012@xjtu.edu.cn
+8618802932796
Backup
Hexiang Yang, Ph.D
clyeah@hotmail.com
+8617791547192
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2030-10-10
Participants
Target number of participants: 360
Treatments
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.
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Xiaoqin Luo

This content was sourced from clinicaltrials.gov