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

May 10, 2026 updated by: Xiaoqin Luo

Study of Nutritional Status and Clinical Outcomes in Patients With Common Malignancies

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 Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1538

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • Xi 'an Jiaotong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Cancer patients from 20 hospitals in Shaanxi Province undergoing chemoradiotherapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Overall Survival (OS) in Cancer Patients
Time Frame: 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.
From date of enrollment until death or last follow-up (up to 5 years)
Progression-Free Survival (PFS) in Cancer Patients
Time Frame: 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.
From date of enrollment until death or last follow-up (up to 5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Total Protein
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Albumin
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Prealbumin
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Transferrin
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
C-Reactive Protein (CRP)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Blood Glucose
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Aspartate Aminotransferase (AST)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Alanine Aminotransferase (ALT)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Interleukin-1 (IL-1)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Tumor Necrosis Factor-alpha (TNF-α)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Creatinine
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Blood Urea Nitrogen
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Total Bilirubin
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Direct Bilirubin
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Total Cholesterol
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Triglycerides
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
High-Density Lipoprotein Cholesterol (HDL-C)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Interleukin-6 (IL-6)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Hemoglobin
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
White Blood Cell Count (Leukocytes)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Neutrophil Count
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Lymphocyte Count
Time Frame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Lymphocyte count (*10⁹/L), measured to evaluate immune competence.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Red Blood Cell Count
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Platelet Count
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Height
Time Frame: 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.
through study completion, an average of 1 year
Body Weight
Time Frame: 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.
through study completion, an average of 1 year
Body Mass Index (BMI)
Time Frame: through study completion, an average of 1 year
BMI calculated as weight (kg) divided by height squared (m²), recorded to one decimal place.
through study completion, an average of 1 year
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 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)
Time Frame: 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).
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Functional Performance Measured by Karnofsky Performance Status (KPS)
Time Frame: 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.
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)
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Changes in Physical Activity Level During Cancer Treatment
Time Frame: 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.
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Changes in Nutrition-Related Knowledge, Attitudes, and Practices (KAP)
Time Frame: 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.
Baseline, 6 months, and 12 months after admission; annually up to 5 years
Healthcare Utilization and Cost of Nutrition-Related Care
Time Frame: 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.
From admission through 30-day post-discharge and annually for 5 years
Incidence of Serious Adverse Events Related to Nutrition or Treatment
Time Frame: 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.
Continuously from enrollment through end of study follow-up (up to 5 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Value of Baseline Nutritional Indicators for 30-Day Clinical Events
Time Frame: Baseline to 30 days post-admission
Evaluation of whether baseline nutritional indicators-including mPG-SGA scores and laboratory biomarkers such as albumin, prealbumin, and CRP-predict 30-day clinical outcomes, including mortality, ICU admission, and significant unintentional weight loss (>5%). Logistic regression will be used for model construction and discrimination.
Baseline to 30 days post-admission
Nutritional Trajectory Typing and Clustering
Time Frame: From baseline to 12-month follow-up
Identification of distinct nutritional change trajectories over time using latent class growth analysis (LCGA) and hierarchical clustering based on serial measurements of mPG-SGA and anthropometric data. Trajectories will be used to classify patients into nutritional risk subgroups.
From baseline to 12-month follow-up
Agreement Between Nutritional Screening Tools (mPG-SGA vs. NRS-2002)
Time Frame: Baseline and each scheduled follow-up visit (up to 5 years)
Assessment of the diagnostic agreement, sensitivity, and specificity of two nutritional screening tools-modified Patient-Generated Subjective Global Assessment (mPG-SGA) and Nutritional Risk Screening 2002 (NRS-2002)-in detecting malnutrition risk. Agreement will be evaluated using Cohen's kappa and ROC curve analysis.
Baseline and each scheduled follow-up visit (up to 5 years)
Sociodemographic Determinants of Malnutrition
Time Frame: From baseline throughout study follow-up (up to 5 years)
Analysis of sociodemographic factors-including income level, education, employment status, and rural vs. urban residence-in predicting baseline malnutrition and nutritional deterioration over time. Multivariable models will be used to explore independent associations.
From baseline throughout study follow-up (up to 5 years)
Patient Adherence to Out-of-Hospital Nutritional Support
Time Frame: Baseline to 12 months post-treatment initiation
Evaluation of patient-reported adherence to prescribed oral nutritional supplements or enteral/parenteral support regimens after hospital discharge. Adherence data will be collected via structured interviews and compared with clinical outcomes and readmission rates.
Baseline to 12 months post-treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaoqin Luo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

December 23, 2023

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1373

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study intends to share IPD with other researchers for advancing scientific understanding and improving patient care. The shared data will include anonymized participant information, such as demographic details, clinical outcomes, and treatment responses. The data will be stripped of any identifiers to ensure participant confidentiality.

IPD Sharing Time Frame

The data will become available after the publication of the main study results, anticipated to be by the end of 2025. The data will be accessible for a period of five years following this date.

IPD Sharing Access Criteria

Researchers interested in accessing the data will be required to submit a proposal outlining their intended use of the data, which will be reviewed by the study's principal investigator. Access will be granted based on the scientific merit and ethical considerations of the proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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