Cancer, Chemoradiotherapy, Clinical Outcomes, Nutrition, Healthy, Oncology
Conditions
Keywords
Chemoradiotherapy, Nutritional Status in Cancer Patients, Clinical Outcomes of Cancer Treatment, Cancer Patient Nutrition, Shaanxi Province Cancer Study
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Xiaoqin Luo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA) | 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) | 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) | 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) | 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) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Total Protein | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Serum total protein concentration (g/L), used to evaluate protein-energy nutritional status. Measured using standard biochemical assays. |
| Serum Albumin | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Serum albumin concentration (g/L), used to assess visceral protein status and systemic inflammation. |
| Serum Prealbumin | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Serum prealbumin level (mg/L), an indicator of short-term changes in protein-energy nutritional status. |
| Serum Transferrin | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Serum transferrin concentration (g/L), a marker of protein status and iron metabolism. |
| C-Reactive Protein (CRP) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Serum CRP (mg/L), a marker of systemic inflammation and acute-phase response. |
| Blood Glucose | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Fasting blood glucose (mmol/L), measured to assess metabolic function and risk of hyperglycemia. |
| Aspartate Aminotransferase (AST) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | AST concentration (U/L), used as a liver function test and hepatotoxicity marker. |
| Alanine Aminotransferase (ALT) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | ALT level (U/L), a liver enzyme measured to monitor hepatic injury. |
| Interleukin-1 (IL-1) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | IL-1 concentration (pg/mL), a pro-inflammatory cytokine indicative of immune and inflammatory activity. |
| Tumor Necrosis Factor-alpha (TNF-α) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Tumor Necrosis Factor-alpha (TNF-α) level (pg/mL) measured to assess systemic inflammation and cancer-related cachexia. |
| Serum Creatinine | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Serum creatinine (μmol/L), measured to evaluate kidney function and treatment-related nephrotoxicity. |
| Blood Urea Nitrogen | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Blood urea nitrogen (umol/L), used to monitor renal function and protein catabolism. |
| Total Bilirubin | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | umol/LBlood urea nitrogen (umol/L), used to monitor renal function and protein catabolism. |
| Direct Bilirubin | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Direct (conjugated) bilirubin (μmol/L), used to evaluate biliary obstruction and liver function. |
| Total Cholesterol | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Total cholesterol level (mmol/L), measured to assess lipid metabolism and nutritional status. |
| Triglycerides | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Serum triglyceride level (mmol/L), used to evaluate energy reserves and lipid metabolism. |
| High-Density Lipoprotein Cholesterol (HDL-C) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | HDL-C (mmol/L), assessed as a marker of cardiovascular health and lipid status. |
| Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | LDL-C (mmol/L), measured as a risk factor for cardiovascular disease and lipid status. |
| Interleukin-6 (IL-6) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | IL-6 level (pg/mL), a pro-inflammatory cytokine measured to monitor systemic inflammation and cachexia. |
| Hemoglobin | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Hemoglobin concentration (\*10⁹/L), used to assess anemia and oxygen-carrying capacity. |
| White Blood Cell Count (Leukocytes) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Total white blood cell count (\*10⁹/L), measured to monitor immune status and detect infection or myelosuppression. |
| Neutrophil Count | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Absolute neutrophil count (\*10⁹/L), used to assess infection risk and bone marrow suppression. |
| Lymphocyte Count | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Lymphocyte count (\*10⁹/L), measured to evaluate immune competence. |
| Red Blood Cell Count | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Red blood cell count (\*10¹²/L), used to assess erythropoiesis and anemia. |
| Platelet Count | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Platelet count (\*10⁹/L), measured to evaluate coagulation status and myelosuppression. |
| Height | through study completion, an average of 1 year | 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. |
| Body Weight | through study completion, an average of 1 year | Body weight (kg) measured using a calibrated scale with 0.2 kg precision. Values adjusted if ascites or edema are present. |
| Body Mass Index (BMI) | through study completion, an average of 1 year | BMI calculated as weight (kg) divided by height squared (m²), recorded to one decimal place. |
| 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 Anxiety Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-A) |
| 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 | 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). |
| Functional Performance Measured by Karnofsky Performance Status (KPS) | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | 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. |
| 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 | 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. |
| Changes in Physical Activity Level During Cancer Treatment | Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years | Assessment of leisure-time physical activity levels (mild, moderate, vigorous) and their relationship with nutritional status and cancer treatment response. |
| Changes in Nutrition-Related Knowledge, Attitudes, and Practices (KAP) | Baseline, 6 months, and 12 months after admission; annually up to 5 years | 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. |
| Healthcare Utilization and Cost of Nutrition-Related Care | From admission through 30-day post-discharge and annually for 5 years | 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. |
| Incidence of Serious Adverse Events Related to Nutrition or Treatment | Continuously from enrollment through end of study follow-up (up to 5 years) | Tracking of serious adverse events potentially related to nutritional support or treatment, including infections, allergic reactions, gastrointestinal distress, and metabolic complications. |
Countries
China
Contacts
CONTACTXiaoqin Luo, Ph.D
CONTACTHexiang Yang, Ph.D
Outcome results
None listed