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.
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: Standardized procedures are used for anthropometric measurements, clinical assessments, and patient-reported outcomes. Nutritional support in and out of hospital, inflammatory biomarkers, liver and kidney function, and hematological indicators are systematically recorded. All data are managed via REDCap with built-in validation, routine audits, and centralized oversight. Quality Assurance and Training: Research personnel at each site undergo rigorous training to ensure consistency in data collection and patient evaluation. Supervisors oversee data quality, coordinate follow-up, and address missing data or protocol deviations. Ethical Oversight: The study adheres to the Declaration of Helsinki and was approved by the Ethics Committee of Xi'an Jiaotong University Health Science Center (Approval No. 2022-1373). Written informed consent is obtained from all participants. All personal data are deidentified and securely stored. Expected Outcomes and Significance: By establishing the temporal relationships between nutritional status and clinical outcomes, the NCOM study will provide high-quality evidence to support individualized nutrition-focused care. Results are expected to improve early identification of patients at risk, optimize nutritional interventions, reduce treatment-related toxicity, and enhance long-term cancer prognosis.
Study Type
OBSERVATIONAL
Enrollment
1,538
Xi 'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGChange 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.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; 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)
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.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Change in Functional Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; 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)
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.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Time frame: From date of enrollment until death or last follow-up (up to 5 years)
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.
Time frame: From date of enrollment until death or last follow-up (up to 5 years)
Serum Total Protein
Serum total protein concentration (g/L), used to evaluate protein-energy nutritional status. Measured using standard biochemical assays.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Albumin
Serum albumin concentration (g/L), used to assess visceral protein status and systemic inflammation.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Prealbumin
Serum prealbumin level (mg/L), an indicator of short-term changes in protein-energy nutritional status.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Transferrin
Serum transferrin concentration (g/L), a marker of protein status and iron metabolism.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
C-Reactive Protein (CRP)
Serum CRP (mg/L), a marker of systemic inflammation and acute-phase response.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Blood Glucose
Fasting blood glucose (mmol/L), measured to assess metabolic function and risk of hyperglycemia.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Aspartate Aminotransferase (AST)
AST concentration (U/L), used as a liver function test and hepatotoxicity marker.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Alanine Aminotransferase (ALT)
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ALT level (U/L), a liver enzyme measured to monitor hepatic injury.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Interleukin-1 (IL-1)
IL-1 concentration (pg/mL), a pro-inflammatory cytokine indicative of immune and inflammatory activity.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Tumor Necrosis Factor-alpha (TNF-α)
Tumor Necrosis Factor-alpha (TNF-α) level (pg/mL) measured to assess systemic inflammation and cancer-related cachexia.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Creatinine
Serum creatinine (μmol/L), measured to evaluate kidney function and treatment-related nephrotoxicity.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Blood Urea Nitrogen
Blood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Total Bilirubin
umol/LBlood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Direct Bilirubin
Direct (conjugated) bilirubin (μmol/L), used to evaluate biliary obstruction and liver function.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Total Cholesterol
Total cholesterol level (mmol/L), measured to assess lipid metabolism and nutritional status.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Triglycerides
Serum triglyceride level (mmol/L), used to evaluate energy reserves and lipid metabolism.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
High-Density Lipoprotein Cholesterol (HDL-C)
HDL-C (mmol/L), assessed as a marker of cardiovascular health and lipid status.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Low-Density Lipoprotein Cholesterol (LDL-C)
LDL-C (mmol/L), measured as a risk factor for cardiovascular disease and lipid status.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Interleukin-6 (IL-6)
IL-6 level (pg/mL), a pro-inflammatory cytokine measured to monitor systemic inflammation and cachexia.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Hemoglobin
Hemoglobin concentration (\*10⁹/L), used to assess anemia and oxygen-carrying capacity.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
White Blood Cell Count (Leukocytes)
Total white blood cell count (\*10⁹/L), measured to monitor immune status and detect infection or myelosuppression.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Neutrophil Count
Absolute neutrophil count (\*10⁹/L), used to assess infection risk and bone marrow suppression.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Lymphocyte Count
Lymphocyte count (\*10⁹/L), measured to evaluate immune competence.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Red Blood Cell Count
Red blood cell count (\*10¹²/L), used to assess erythropoiesis and anemia.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Platelet Count
Platelet count (\*10⁹/L), measured to evaluate coagulation status and myelosuppression.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Time frame: through study completion, an average of 1 year
Body Weight
Body weight (kg) measured using a calibrated scale with 0.2 kg precision. Values adjusted if ascites or edema are present.
Time frame: through study completion, an average of 1 year
Body Mass Index (BMI)
BMI calculated as weight (kg) divided by height squared (m²), recorded to one decimal place.
Time frame: through study completion, an average of 1 year
Change in Anxiety Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-A)
Change in Anxiety Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-A)
Time frame: 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)
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).
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Time frame: 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)
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.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Time frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
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.
Time frame: Baseline, 6 months, and 12 months after admission; annually up to 5 years
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.
Time frame: From admission through 30-day post-discharge and annually for 5 years
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.
Time frame: Continuously from enrollment through end of study follow-up (up to 5 years)