Study of Nutritional Status and Clinical Outcomes in Patients With Common Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,538
- 试验地点
- 1
- 主要终点
- Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA)
研究概览
简要总结
This multicenter, prospective cohort study investigates the long-term impact of nutritional status on clinical outcomes in cancer patients undergoing treatment in Shaanxi Province, China. It evaluates how malnutrition, dietary patterns, and nutritional interventions affect treatment tolerance, quality of life, and survival. The study tracks dynamic changes in nutritional health and related indicators throughout various stages of chemoradiotherapy, aiming to inform evidence-based strategies for precision nutrition in oncology care.
详细描述
Study Purpose and Objectives:
The Nutritional Status and Clinical Outcomes in Patients with Common Malignancies (NCOM) study aims to assess how nutritional status influences treatment-related complications, functional performance, psychosocial well-being, and long-term survival in cancer patients. By capturing longitudinal data, the study seeks to identify modifiable risk factors and develop predictive models to support personalized nutritional interventions in oncology.
Study Design and Scope:
The study is being conducted at 11 tertiary hospitals across Xi'an, Shaanxi Province, and will recruit a total of 1,538 patients diagnosed with common malignancies. Participants are enrolled within 48 hours of hospital admission and followed at structured intervals over a five-year period: at 1, 2, 3, 6, and 12 months, and then annually. Baseline and follow-up evaluations include demographic data, cancer-specific clinical characteristics, nutritional risk (mPG-SGA, NRS-2002), dietary intake (SDSAT), quality of life (EORTC QLQ-C30), psychosocial health (HADS), physical activity, sleep quality (PSQI), and laboratory biomarkers.
Data Collection and Management:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and above
- •Pathologically diagnosed with malignant tumors
- •Scheduled to undergo radiotherapy and/or chemotherapy
- •Clear consciousness, no communication barriers
- •Willing to undergo follow-up, not in a near-death condition
排除标准
- •Patients without a pathological diagnosis of malignant tumors
- •Patients with AIDS
- •Patients with mental or cognitive disorders
- •Patients who have undergone organ transplantation
- •Patients with a life expectancy less than 12 months
- •Pregnant women
- •Patients currently participating in other clinical intervention studies
结局指标
主要结局
Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA)
时间窗: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Change in Nutritional Risk Assessed by Nutritional Risk Screening 2002 (NRS-2002)
时间窗: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Change in Global Health Status Score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
时间窗: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Change in Functional Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
时间窗: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Evaluation of physical, role, emotional, cognitive, and social functioning domains using the functional scales of the EORTC QLQ-C30. Each domain score ranges from 0 to 100, with higher scores representing better functioning. Each domain will be reported separately.
Change in Symptom Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
时间窗: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Overall Survival (OS) in Cancer Patients
时间窗: From date of enrollment until death or last follow-up (up to 5 years)
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.
Progression-Free Survival (PFS) in Cancer Patients
时间窗: From date of enrollment until death or last follow-up (up to 5 years)
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.
次要结局
- Serum Total Protein(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Serum Albumin(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Serum Prealbumin(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Serum Transferrin(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- C-Reactive Protein (CRP)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Blood Glucose(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Aspartate Aminotransferase (AST)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Alanine Aminotransferase (ALT)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Interleukin-1 (IL-1)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Tumor Necrosis Factor-alpha (TNF-α)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Serum Creatinine(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Blood Urea Nitrogen(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Total Bilirubin(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Direct Bilirubin(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Total Cholesterol(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Triglycerides(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- High-Density Lipoprotein Cholesterol (HDL-C)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Interleukin-6 (IL-6)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Hemoglobin(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- White Blood Cell Count (Leukocytes)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Neutrophil Count(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Lymphocyte Count(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Red Blood Cell Count(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Platelet Count(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Height(through study completion, an average of 1 year)
- Body Weight(through study completion, an average of 1 year)
- Body Mass Index (BMI)(through study completion, an average of 1 year)
- Change in Anxiety Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-A)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Change in Depression Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-D)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Functional Performance Measured by Karnofsky Performance Status (KPS)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Changes in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Changes in Physical Activity Level During Cancer Treatment(Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years)
- Changes in Nutrition-Related Knowledge, Attitudes, and Practices (KAP)(Baseline, 6 months, and 12 months after admission; annually up to 5 years)
- Healthcare Utilization and Cost of Nutrition-Related Care(From admission through 30-day post-discharge and annually for 5 years)
- Incidence of Serious Adverse Events Related to Nutrition or Treatment(Continuously from enrollment through end of study follow-up (up to 5 years))
研究者
Xiaoqin Luo
Professor
Xi'an Jiaotong University