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A Cohort Study Protocol of Nutritional Status and Clinical Outcomes in Patients With Common Malignancies (NCOM Study)
Hexiang Yang1, Yaxin Yu1, Haige Cao1
1Department of Nutrition and Food Safety, School of Public Health Xi'an Jiaotong University Xi'an China.
Abstract:
Malnutrition is common among patients with cancer and is associated with poorer treatment tolerance, impaired quality of life, and reduced survival. However, evidence regarding the relationship between longitudinal changes in nutritional status and clinical outcomes remains limited. The Nutritional Status and Clinical Outcomes in Patients with Common Malignancies (NCOM) study is an ongoing prospective, multicenter cohort in China. Patients are recruited from 11 hospitals and undergo nutritional assessments conducted within 48 h of admission. Follow-up is scheduled at 1, 2, 3, 6, and 12 months, followed by annual assessments for an additional 4 years. Baseline nutritional status, assessed using the Modified Patient-Generated Subjective Global Assessment (mPG-SGA), is the primary exposure. The primary nutritional and clinical outcomes are longitudinal change in mPG-SGA and overall survival, respectively. The cohort also captures clinical information, dietary assessment, nutritional support, biomarkers, quality of life, psychosocial factors, physical activity, sleep, nutrition-related knowledge, attitudes and practices, adverse events, and survival outcomes. Preliminary baseline data from 604 enrolled patients indicated substantial nutritional impairment. According to the mPG-SGA, 58.61% were classified as having moderate or severe malnutrition, whereas 23.34% were at nutritional risk by the NRS-2002. These findings support early identification and longitudinal nutritional monitoring in oncology care. Continued follow-up will enable evaluation of nutritional trajectories and their associations with treatment tolerance, patient-centered outcomes, and survival. Trial Registration: ClinicalTrials.gov: NCT06219083.
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