About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and above
Pathologically diagnosed with malignant tumors
Scheduled to undergo radiotherapy and/or chemotherapy
Clear consciousness, no communication barriers
Disqualifiers
Patients without a pathological diagnosis of malignant tumors
Patients with AIDS
Patients with mental or cognitive disorders
Patients who have undergone organ transplantation
Trial population
Cancer patients from 20 hospitals in Shaanxi Province undergoing chemoradiotherapy.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA)
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)
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)
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)
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.
Secondary outcomes
Serum Total Protein
Serum total protein concentration (g/L), used to evaluate protein-energy nutritional status. Measured using standard biochemical assays.
Serum Albumin
Serum albumin concentration (g/L), used to assess visceral protein status and systemic inflammation.
Serum Prealbumin
Serum prealbumin level (mg/L), an indicator of short-term changes in protein-energy nutritional status.
Serum Transferrin
Serum transferrin concentration (g/L), a marker of protein status and iron metabolism.
Other outcomes
Predictive Value of Baseline Nutritional Indicators for 30-Day Clinical Events
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.
Nutritional Trajectory Typing and Clustering
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.
Agreement Between Nutritional Screening Tools (mPG-SGA vs. NRS-2002)
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.
Sociodemographic Determinants of Malnutrition
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiaoqin Luo
Lead sponsor
Xi'an Jiaotong University
Sponsor institution