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

Official title

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

Overview

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.

Primary outcome measures

• 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]
• 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]
• 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]
• 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]
• 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]
• Overall Survival (OS) in Cancer Patients [Time frame: 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)]

Secondary outcome measures (12)

• Serum Total Protein [Time frame: 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 Prealbumin [Time frame: 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]
• C-Reactive Protein (CRP) [Time frame: 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]
• Aspartate Aminotransferase (AST) [Time frame: 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]
• Interleukin-1 (IL-1) [Time frame: 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]
• Serum Creatinine [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

China · 1 center

• Xi 'an Jiaotong University — Xi'an

Publications

• Baracos VE. Cancer-associated malnutrition. Eur J Clin Nutr. 2018 Sep;72(9):1255-1259. doi: 10.1038/s41430-018-0245-4. Epub 2018 Sep 5. No abstract available. PMID 30185853
• Muscaritoli M, Corsaro E, Molfino A. Awareness of Cancer-Related Malnutrition and Its Management: Analysis of the Results From a Survey Conducted Among Medical Oncologists. Front Oncol. 2021 May 13;11:682999. doi: 10.3389/fonc.2021.682999. eCollection 2021. PMID 34055649
• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
• Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108. PMID 35143424
• Morgan E, Arnold M, Gini A, Lorenzoni V, Cabasag CJ, Laversanne M, Vignat J, Ferlay J, Murphy N, Bray F. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Gut. 2023 Feb;72(2):338-344. doi: 10.1136/gutjnl-2022-327736. Epub 2022 Sep 8. PMID 36604116
• Zhou J, Zheng R, Zhang S, Zeng H, Wang S, Chen R, Sun K, Li M, Gu J, Zhuang G, Wei W. Colorectal cancer burden and trends: Comparison between China and major burden countries in the world. Chin J Cancer Res. 2021 Feb 28;33(1):1-10. doi: 10.21147/j.issn.1000-9604.2021.01.01. PMID 33707923
• Argiles JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. doi: 10.1016/j.ejon.2005.09.006. PMID 16437757
• Hebuterne X, Lemarie E, Michallet M, de Montreuil CB, Schneider SM, Goldwasser F. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):196-204. doi: 10.1177/0148607113502674. PMID 24748626

Identifiers

NCT: NCT06219083 · 2022-1373

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗