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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXiaoqin Luo

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
2

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.

Time frame
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
3

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.

Time frame
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
4

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.

Time frame
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years

Secondary outcomes

1

Serum Total Protein

Serum total protein concentration (g/L), used to evaluate protein-energy nutritional status. Measured using standard biochemical assays.

Time frame
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
2

Serum Albumin

Serum albumin concentration (g/L), used to assess visceral protein status and systemic inflammation.

Time frame
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
3

Serum Prealbumin

Serum prealbumin level (mg/L), an indicator of short-term changes in protein-energy nutritional status.

Time frame
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
4

Serum Transferrin

Serum transferrin concentration (g/L), a marker of protein status and iron metabolism.

Time frame
Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years

Other outcomes

1

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.

Time frame
Baseline to 30 days post-admission
2

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.

Time frame
From baseline to 12-month follow-up
3

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.

Time frame
Baseline and each scheduled follow-up visit (up to 5 years)
4

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.

Time frame
From baseline throughout study follow-up (up to 5 years)

Sponsors and contacts

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Xiaoqin Luo

Lead sponsor

Xi'an Jiaotong University

Sponsor institution