Nutritional Status and Clinical Outcomes in Patients With Common Malignancies(NCOM)

Recruiting

• Conditions: Chemoradiotherapy; Cancer; Nutrition, Healthy; Oncology; Clinical Outcomes

• Registration Number: NCT06219083
• Lead Sponsor: Xiaoqin Luo

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.

Study Timeline

• Study Start: 2020-11-12
• Study First Submitted: 2023-12-23
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-23
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Primary Completion: 2030-12-01
• Study Completion: 2031-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1538

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Xi 'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China