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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Personalized Oral Nutritional Supplementation
  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 targe
• Препарат Personalized Parenteral Nutritional Supplementation
  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.
• Поведенческое Structured Nutrition-Focused Health Education
  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 acces

Первичные конечные точки

• Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA) [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Change in Global Health Status Score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Change in Symptom Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Overall Survival (OS) in Cancer Patients [Срок оценки: From date of enrollment until death or last follow-up (up to 5 years)]
• Progression-Free Survival (PFS) in Cancer Patients [Срок оценки: From date of enrollment until death or last follow-up (up to 5 years)]

Вторичные конечные точки (12)

• Change in Nutritional Risk Assessed by Nutritional Risk Screening 2002 (NRS-2002) [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Serum Total Protein [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Serum Albumin [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Serum Prealbumin [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Serum Transferrin [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• C-Reactive Protein (CRP) [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Blood Glucose [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Aspartate Aminotransferase (AST) [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Alanine Aminotransferase (ALT) [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Interleukin-1 (IL-1) [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Tumor Necrosis Factor-alpha (TNF-α) [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]
• Serum Creatinine [Срок оценки: Baseline, after the intervention, 1, 2, 3, 6, and 12 months after intervention; annually up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Xi 'an Jiaotong University — Сиань

Публикации

• 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. PMID 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 3 PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 37014956

Идентификаторы

NCT: NCT07087561 · No: XJTU1AF2025LSYY-016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗