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Colorectal Cancer (Diagnosis)NUTRI-CRCNCT07087561

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

A study testing Personalized Oral Nutritional Supplementation, Personalized Parenteral Nutritional Supplementation and Structured Nutrition-Focused Health Education in people with Colorectal Cancer (Diagnosis) and Malnutrition or Risk of Malnutrition, run by Xiaoqin Luo at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Personalized Oral Nutritional Supplementation, Personalized Parenteral Nutritional Supplementation and Structured Nutrition-Focused Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteChina
Study dates
10 Oct 2024to 10 Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoqin Luo, Ph.D contact

+8618802932796

luoxiaoqin2012@xjtu.edu.cn

Hexiang Yang, Ph.D contact

+8617791547192

clyeah@hotmail.com

China1 site, 1 recruiting

  • Xi 'an Jiaotong University

    Xi'an, Shaanxi, 710000

    Xiaoqin luo, Ph.D, +8618802932796, luoxiaoqin2012@xjtu.edu.cn

    Hexiang Yang, Ph.D, +8617791547192, clyeah@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: 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 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.

Read more

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.

Read the detailed description

This is a prospective, multicenter, open-label, randomized controlled clinical trial designed to assess the effects and underlying mechanisms of short-term nutritional enhancement combined with health education on clinical outcomes in patients undergoing surgery for non-metastatic colorectal cancer (stages IIa, IIb, IIIa). The rationale is based on the high prevalence of malnutrition among CRC patients, which significantly impacts treatment tolerance, quality of life, and long-term prognosis.

Eligible participants will be randomized into four parallel arms: (1) individualized nutritional enhancement plus structured health education; (2) structured health education alone; (3) individualized nutritional enhancement alone; and (4) standard care without additional intervention. Personalized nutrition plans will be developed based on energy and protein needs, supported by dietary counseling and the provision of oral nutritional supplements. Health education will be delivered through a digital platform, featuring weekly videos and interactive content on nutrition, exercise, and psychological well-being.

The study includes a 14-day intervention phase and a 12-month follow-up period. Outcomes will be assessed at baseline, and at 1, 2, 3, 6, and 12 months, and annually up to 5 years to evaluate both clinical outcomes and biological markers of response.post-intervention. Key endpoints include improvements in nutritional status, patient-reported quality of life, and overall survival metrics.

To investigate mechanisms, the study incorporates biological sampling and multi-omics analysis. Non-targeted serum metabolomics, gut microbiota metagenomics, and single-cell RNA sequencing of tumor and adjacent normal tissues will be used to characterize metabolic and immune changes associated with the interventions. The study also evaluates the role of inflammatory markers and immune cell profiles in mediating clinical effects.

This trial is expected to generate high-quality evidence supporting the integration of nutrition and health education strategies into standard postoperative care for CRC patients. It may also identify novel metabolic or microbial biomarkers associated with treatment response and prognosis, contributing to the development of precision nutrition approaches in oncology.

Being tested
Personalized Oral Nutritional Supplementation, Personalized Parenteral Nutritional Supplementation, Structured Nutrition-Focused Health Education
Keywords
Colorectal Cancer, Nutrition Support, Health Education, Patient-Reported Outcomes, Nutritional Risk, Cancer Rehabilitation, Randomized Controlled Trial
Medical subject headings
Colorectal Neoplasms, Disease, Malnutrition, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Oral Nutritional SupplementationDietary supplement

    Also called ONS

    Participants receive individualized oral nutritional supplementation based on energy and protein requirements, calculated using the Harris-Benedict equation and body weight (1.2-1.5 g protein/kg/day). The supplement may include complete nutrition powder, whey protein powder, and compound multivitamins. The intervention is prescribed and monitored by a clinical nutrition team and adjusted every 3 days during the 14-day intervention phase. The goal is to ensure both energy and protein intake targets are met. Supplements are administered in addition to standard meals.

  • Personalized Parenteral Nutritional SupplementationDrug

    Also called PN

    For participants unable to meet nutritional goals through oral intake, parenteral nutrition is administered intravenously. The formulation includes amino acids, glucose, lipids, electrolytes, trace elements, and vitamins. Dosages are aligned with those of the enteral nutrition group, ensuring a consistent intake of energy and protein (1.2-1.5 g/kg/day protein). Formulation and administration follow standardized hospital protocols and are supervised by the nutrition support team.

  • Structured Nutrition-Focused Health EducationBehavioural

    Also called Internet-Based Health Education, Multimedia Health Literacy Intervention

    Participants receive structured health education focused on nutrition, physical activity, and psychological well-being. The education is delivered over 14 days using a digital "Internet Plus" platform, featuring weekly videos, interactive Q\&A sessions, and guidance from a multidisciplinary nutrition support team. Educational content covers dietary recommendations, exercise safety, stress management, and post-treatment recovery strategies. Materials are updated weekly, and participants may access them remotely via smartphone or tablet. This intervention aims to improve nutrition knowledge, adherence, and health behavior change.

Study groups in NCT07087561
Study groupRoleWhat they receive
Nutritional Enhancement Plus Health EducationExperimentalParticipants 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.
Receives: Dietary Supplement: Personalized Oral Nutritional Supplementation; Drug: Personalized Parenteral Nutritional Supplementation; Behavioral: Structured Nutrition-Focused Health Education
Health Education OnlyExperimentalParticipants 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.
Receives: Behavioral: Structured Nutrition-Focused Health Education
Nutritional Enhancement OnlyExperimentalParticipants 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.
Receives: Dietary Supplement: Personalized Oral Nutritional Supplementation; Drug: Personalized Parenteral Nutritional Supplementation
Standard Care (Control)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA)

    Longitudinal assessment of nutritional status using the mPG-SGA, a validated tool composed of five sections (weight loss history, dietary intake, symptoms, function/activity, and age). Total scores range from 0 to ≥7 points, with higher scores indicating worse nutritional status. Patients will be classified as:

    0-2 = Normal

    3-6 = Mild malnutrition

    ≥7 = Moderate to severe malnutrition.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  2. Change in Global Health Status Score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Assessment of patients' perceived overall health status using the global health subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores range from 0 to 100, with higher scores indicating better global quality of life.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  3. Change in Symptom Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Assessment of symptom burden including fatigue, pain, nausea/vomiting, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulty using symptom subscales of the EORTC QLQ-C30. Each symptom is scored separately from 0 to 100, with higher scores indicating worse symptom severity.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  4. Overall Survival (OS) in Cancer Patients

    Overall survival is defined as the time from the date of enrollment to the date of death from any cause. Patients still alive at the last follow-up will be censored. Kaplan-Meier survival analysis and Cox proportional hazards regression will be used to estimate survival and explore associations with baseline and longitudinal nutritional status.

    Measured: From date of enrollment until death or last follow-up (up to 5 years)

  5. Progression-Free Survival (PFS) in Cancer Patients

    Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first. Patients without progression at the time of last follow-up will be censored. PFS will be analyzed using Kaplan-Meier estimates and Cox regression models, stratified by nutritional status.

    Measured: From date of enrollment until death or last follow-up (up to 5 years)

Secondary outcomes (36)

  1. Change in Nutritional Risk Assessed by Nutritional Risk Screening 2002 (NRS-2002)

    Longitudinal evaluation of nutritional risk using the NRS-2002, which considers disease severity, nutritional impairment, and age. Total score ranges from 0 to ≥7 points. A score of ≥3 indicates nutritional risk and warrants intervention; <3 indicates no immediate risk.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  2. Serum Total Protein

    Serum total protein concentration (g/L), used to evaluate protein-energy nutritional status. Measured using standard biochemical assays.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  3. Serum Albumin

    Serum albumin concentration (g/L), used to assess visceral protein status and systemic inflammation.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  4. Serum Prealbumin

    Serum prealbumin level (mg/L), an indicator of short-term changes in protein-energy nutritional status.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  5. Serum Transferrin

    Serum transferrin concentration (g/L), a marker of protein status and iron metabolism.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  6. C-Reactive Protein (CRP)

    Serum CRP (mg/L), a marker of systemic inflammation and acute-phase response.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  7. Blood Glucose

    Fasting blood glucose (mmol/L), measured to assess metabolic function and risk of hyperglycemia.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  8. Aspartate Aminotransferase (AST)

    AST concentration (U/L), used as a liver function test and hepatotoxicity marker.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  9. Alanine Aminotransferase (ALT)

    ALT level (U/L), a liver enzyme measured to monitor hepatic injury.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  10. Interleukin-1 (IL-1)

    IL-1 concentration (pg/mL), a pro-inflammatory cytokine indicative of immune and inflammatory activity.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  11. Tumor Necrosis Factor-alpha (TNF-α)

    Tumor Necrosis Factor-alpha (TNF-α) level (pg/mL) measured to assess systemic inflammation and cancer-related cachexia.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  12. Serum Creatinine

    Serum creatinine (μmol/L), measured to evaluate kidney function and treatment-related nephrotoxicity.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  13. Blood Urea Nitrogen

    Blood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  14. Total Bilirubin

    Blood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  15. Total Cholesterol

    Total cholesterol level (mmol/L), measured to assess lipid metabolism and nutritional status.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  16. Triglycerides

    Serum triglyceride level (mmol/L), used to evaluate energy reserves and lipid metabolism.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  17. High-Density Lipoprotein Cholesterol (HDL-C)

    HDL-C (mmol/L), assessed as a marker of cardiovascular health and lipid status.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  18. Low-Density Lipoprotein Cholesterol (LDL-C)

    LDL-C (mmol/L), measured as a risk factor for cardiovascular disease and lipid status.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  19. Interleukin-6 (IL-6)

    IL-6 level (pg/mL), a pro-inflammatory cytokine measured to monitor systemic inflammation and cachexia.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  20. Hemoglobin

    Hemoglobin concentration (*10⁹/L), used to assess anemia and oxygen-carrying capacity.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  21. White Blood Cell Count (Leukocytes)

    Total white blood cell count (*10⁹/L), measured to monitor immune status and detect infection or myelosuppression.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  22. Neutrophil Count

    Absolute neutrophil count (*10⁹/L), used to assess infection risk and bone marrow suppression.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  23. Lymphocyte Count

    Lymphocyte count (*10⁹/L), measured to evaluate immune competence.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  24. Red Blood Cell Count

    Red blood cell count (*10¹²/L), used to assess erythropoiesis and anemia.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  25. Platelet Count

    Platelet count (*10⁹/L), measured to evaluate coagulation status and myelosuppression.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  26. Height

    Standing height (cm) measured using a stadiometer with 0.5 cm precision. Values adjusted for presence of ascites, edema, or large tumors.ascites, systemic edema, and huge tumors.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  27. Body Weight

    Body weight (kg) measured using a calibrated scale with 0.2 kg precision. Values adjusted if ascites or edema are present.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  28. Body Mass Index (BMI)

    BMI calculated as weight (kg) divided by height squared (m²), recorded to one decimal place.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  29. Change in Anxiety Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-A)

    Assessment of anxiety using the HADS-A subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Results will be analyzed in relation to nutritional status (normal, mild, moderate malnutrition).

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  30. Change in Depression Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-D)

    Assessment of depressive symptoms using the HADS-D subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe depression. Results will be analyzed in relation to nutritional status (normal, mild, moderate malnutrition).

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  31. Functional Performance Measured by Karnofsky Performance Status (KPS)

    Functional performance will be evaluated using the Karnofsky Performance Status (KPS) scale, which ranges from 0 to 100. Higher scores indicate better functional ability and independence in daily activities. Longitudinal KPS changes will be assessed in relation to changes in nutritional status over time.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  32. Changes in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)

    Sleep quality and disturbances will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a standardized questionnaire assessing seven components of sleep. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. PSQI scores will be analyzed in relation to nutritional risk categories and treatment phases.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  33. Changes in Physical Activity Level During Cancer Treatment

    Assessment of leisure-time physical activity levels (mild, moderate, vigorous) and their relationship with nutritional status and cancer treatment response.

    Measured: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years

  34. Changes in Nutrition-Related Knowledge, Attitudes, and Practices (KAP)

    Patients' dietary knowledge, attitudes, and practices will be assessed using a validated Nutrition KAP (Knowledge, Attitude, and Practice) questionnaire. The total score ranges from 0 to 104, with higher scores indicating better nutritional knowledge, more positive attitudes, and healthier dietary behaviors. Longitudinal changes in KAP scores will be evaluated in relation to treatment outcomes.

    Measured: Baseline, after the intervention, 6 months after intervention; annually up to 5 years

  35. Healthcare Utilization and Cost of Nutrition-Related Care

    Evaluation of healthcare utilization related to nutritional care, including total number of hospitalization days, number of ICU admissions, and direct costs associated with enteral and parenteral nutrition support. Metrics will be analyzed in relation to malnutrition risk at baseline and during treatment.

    Measured: From admission through 30-day post-discharge and annually for 5 years

  36. Incidence of Serious Adverse Events Related to Nutrition or Treatment

    Tracking of serious adverse events potentially related to nutritional support or treatment, including infections, allergic reactions, gastrointestinal distress, and metabolic complications.

    Measured: Continuously from enrollment through end of study follow-up (up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2025
  2. Study start10 Oct 2024
  3. Primary completion10 Oct 2029 (estimated)
  4. Study completion10 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, multicenter, open-label, parallel-group randomized controlled trial involving four intervention arms. Participants are assigned in a 1:1:1:1 ratio to one of the following: (A) short-term nutritional enhancement combined with health education, (B) health education alone, (C) nutritional enhancement alone, or (D) standard care. Stratified randomization is performed based on baseline nutritional status and cancer stage to ensure group balance.
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07087561
Sponsor's protocol ID
No: XJTU1AF2025LSYY-016
Acronym
NUTRI-CRC
Status last verified
Jul 2025
First submitted
18 Jul 2025
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study intends to share IPD with other researchers for advancing scientific understanding and improving patient care. The shared data will include anonymized participant information, such as demographic details, clinical outcomes, and treatment responses. The data will be stripped of any identifiers to ensure participant confidentiality.

Publications

  • Yang Y, Han Z, Li X, Huang A, Shi J, Gu J. Epidemiology and risk factors of colorectal cancer in China. Chin J Cancer Res. 2020 Dec 31;32(6):729-741. doi: 10.21147/j.issn.1000-9604.2020.06.06.

    PubMed 33446996

  • Bennell KL, Lawford BJ, Keating C, Brown C, Kasza J, Mackenzie D, Metcalf B, Kimp AJ, Egerton T, Spiers L, Proietto J, Sumithran P, Harris A, Quicke JG, Hinman RS. Comparing Video-Based, Telehealth-Delivered Exercise and Weight Loss Programs With Online Education on Outcomes of Knee Osteoarthritis : A Randomized Trial. Ann Intern Med. 2022 Feb;175(2):198-209. doi: 10.7326/M21-2388. Epub 2021 Nov 30.

    PubMed 34843383

  • Ratri DMN, Hamidah KF, Puspitasari AD, Farid M. Video-based health education to support insulin therapy in diabetes mellitus patients. J Public Health Res. 2020 Jul 3;9(2):1849. doi: 10.4081/jphr.2020.1849. eCollection 2020 Jul 3.

    PubMed 32728588

  • Adam M, Young-Wolff KC, Konar E, Winkleby M. Massive open online nutrition and cooking course for improved eating behaviors and meal composition. Int J Behav Nutr Phys Act. 2015 Dec 3;12:143. doi: 10.1186/s12966-015-0305-2.

    PubMed 26630879

  • Wang Y, Wang Y, Xu C, Liu Y, Huang Z. Identification of Novel Tumor-Microenvironment-Regulating Factor That Facilitates Tumor Immune Infiltration in Colon Cancer. Mol Ther Nucleic Acids. 2020 Aug 29;22:236-250. doi: 10.1016/j.omtn.2020.08.029. eCollection 2020 Dec 4.

    PubMed 33230430

  • Brown TE, Banks MD, Hughes BGM, Lin CY, Kenny LM, Bauer JD. Randomised controlled trial of early prophylactic feeding vs standard care in patients with head and neck cancer. Br J Cancer. 2017 Jun 27;117(1):15-24. doi: 10.1038/bjc.2017.138. Epub 2017 May 23.

    PubMed 28535154

  • Murphy JL, Munir F, Davey F, Miller L, Cutress R, White R, Lloyd M, Roe J, Granger C, Burden S, Turner L. The provision of nutritional advice and care for cancer patients: a UK national survey of healthcare professionals. Support Care Cancer. 2021 May;29(5):2435-2442. doi: 10.1007/s00520-020-05736-y. Epub 2020 Sep 12.

    PubMed 32918612

  • Liu Y, Zhang H, Dove WF, Wang Z, Zhu Z, Pickhardt PJ, Reichelderfer M, Li L. Quantification of Serum Metabolites in Early Colorectal Adenomas Using Isobaric Labeling Mass Spectrometry. J Proteome Res. 2023 May 5;22(5):1483-1491. doi: 10.1021/acs.jproteome.3c00006. Epub 2023 Apr 4.

    PubMed 37014956

  • Liu Y, Lau HC, Yu J. Microbial metabolites in colorectal tumorigenesis and cancer therapy. Gut Microbes. 2023 Jan-Dec;15(1):2203968. doi: 10.1080/19490976.2023.2203968.

    PubMed 37095682

  • Niekamp P, Kim CH. Microbial Metabolite Dysbiosis and Colorectal Cancer. Gut Liver. 2023 Mar 15;17(2):190-203. doi: 10.5009/gnl220260. Epub 2023 Jan 12.

    PubMed 36632785

  • Louis P, Hold GL, Flint HJ. The gut microbiota, bacterial metabolites and colorectal cancer. Nat Rev Microbiol. 2014 Oct;12(10):661-72. doi: 10.1038/nrmicro3344. Epub 2014 Sep 8.

    PubMed 25198138

  • Liu H, Lei W, Li Z, Wang X, Zhou L. NR3C2 inhibits the proliferation of colorectal cancer via regulating glucose metabolism and phosphorylating AMPK. J Cell Mol Med. 2023 Apr;27(8):1069-1082. doi: 10.1111/jcmm.17706. Epub 2023 Mar 23.

    PubMed 36950803

  • Tabata S, Kojima Y, Sakamoto T, Igarashi K, Umetsu K, Ishikawa T, Hirayama A, Kajino-Sakamoto R, Sakamoto N, Yasumoto KI, Okano K, Suzuki Y, Yachida S, Aoki M, Soga T. L-2hydroxyglutaric acid rewires amino acid metabolism in colorectal cancer via the mTOR-ATF4 axis. Oncogene. 2023 Apr;42(16):1294-1307. doi: 10.1038/s41388-023-02632-7. Epub 2023 Mar 6.

    PubMed 36879117

  • Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. J Clin Oncol. 2005 Mar 1;23(7):1431-8. doi: 10.1200/JCO.2005.02.054. Epub 2005 Jan 31.

    PubMed 15684319

  • Lu Z, Fang Y, Liu C, Zhang X, Xin X, He Y, Cao Y, Jiao X, Sun T, Pang Y, Wang Y, Zhou J, Qi C, Gong J, Wang X, Li J, Tang L, Shen L. Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial. J Clin Oncol. 2021 Mar 1;39(7):748-756. doi: 10.1200/JCO.20.01254. Epub 2021 Jan 8.

    PubMed 33417481

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Oral Nutritional Supplementation, Personalized Parenteral Nutritional Supplementation and Structured Nutrition-Focused Health Education in people with Colorectal Cancer (Diagnosis) and Malnutrition or Risk of Malnutrition, run by Xiaoqin Luo at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoqin Luo, Ph.D (+8618802932796, luoxiaoqin2012@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA) (time frame: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07087561, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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