Short-term personalized nutrition plus health education after colorectal cancer surgery
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
This study tests whether a short course of tailored nutritional supplements together with digital health education helps people who had surgery for stage II–IIIa colorectal cancer improve nutrition, quality of life, and recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT07087561 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label, multicenter trial that will enroll about 360 patients who have had surgery for non-metastatic colorectal cancer and are at nutritional risk. Participants are randomly assigned to one of four groups: personalized nutritional support plus structured health education, health education alone, nutritional support alone, or standard care. Nutritional support includes individualized diet counseling and oral (or parenteral when needed) supplements, while health education is delivered via a digital platform with weekly videos and interactive content. The intervention lasts 14 days with clinical and patient-reported outcomes assessed at multiple time points up to 12 months and annual follow-up for long-term outcomes.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed stage IIa–IIIa colon or rectal cancer who have undergone surgery, are at nutritional risk, are mentally able to participate, and expect to survive more than six months are eligible.
Not a fit: Patients without nutritional risk, with metastatic disease, severe uncontrolled comorbidities, pregnancy, organ transplantation, or known allergy to the supplements are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the combination could lead to better nutritional status, improved quality of life, faster recovery, and potentially better long-term outcomes after colorectal cancer surgery.
How similar studies have performed: Previous research has shown perioperative nutritional support can improve postoperative recovery and quality of life, though combining short-term personalized supplementation with a structured digital education program is less well studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Xi'an, Shaanxi
- Xi 'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Xiaoqin Luo, Ph.D
- Email: luoxiaoqin2012@xjtu.edu.cn
- Phone: +8618802932796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.