NCT07087561 Short-Term Nutritional Enhancement Combined With Health Education in Postoperative Colorectal Cancer Patients: A Randomized Controlled Trial
| NCT ID | NCT07087561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiaoqin Luo |
| Condition | Colorectal Cancer (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2029-10-10 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2024-10-10 with a primary completion date of 2029-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07087561 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07087561 currently recruiting?
Yes, NCT07087561 is actively recruiting participants. Contact the research team at luoxiaoqin2012@xjtu.edu.cn for enrollment information.
Where is the NCT07087561 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07087561 clinical trial?
NCT07087561 is sponsored by Xiaoqin Luo. The trial plans to enroll 360 participants.
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