CancerNCOMNCT06219083
Nutritional Status and Clinical Outcomes in Patients With Common Malignancies(NCOM)
An observational study of Cancer and Chemoradiotherapy, run by Xiaoqin Luo at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemoradiotherapy, Nutrition, Healthy
- How many people
- 1,538 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2020to 1 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Cancer patients from 20 hospitals in Shaanxi Province undergoing chemoradiotherapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xi 'an Jiaotong University
Xi'an, Shaanxi, 710061
Xiaoqin Luo, Ph.D, +8617791547192, clyeah@hotmail.com
Hexiang Yang, Ph.D, +8617782582639, 592518222@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Chemoradiotherapy, Nutrition, Healthy, Oncology, Clinical Outcomes
- Keywords
- Chemoradiotherapy, Nutritional Status in Cancer Patients, Clinical Outcomes of Cancer Treatment, Cancer Patient Nutrition, Shaanxi Province Cancer Study
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Overall Survival (OS) in Cancer Patients
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.
Measured: From date of enrollment until death or last follow-up (up to 5 years)
Progression-Free Survival (PFS) in Cancer Patients
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.
Measured: From date of enrollment until death or last follow-up (up to 5 years)
Secondary outcomes (36)
Serum Total Protein
Serum total protein concentration (g/L), used to evaluate protein-energy nutritional status. Measured using standard biochemical assays.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Albumin
Serum albumin concentration (g/L), used to assess visceral protein status and systemic inflammation.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Prealbumin
Serum prealbumin level (mg/L), an indicator of short-term changes in protein-energy nutritional status.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Transferrin
Serum transferrin concentration (g/L), a marker of protein status and iron metabolism.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
C-Reactive Protein (CRP)
Serum CRP (mg/L), a marker of systemic inflammation and acute-phase response.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Blood Glucose
Fasting blood glucose (mmol/L), measured to assess metabolic function and risk of hyperglycemia.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Aspartate Aminotransferase (AST)
AST concentration (U/L), used as a liver function test and hepatotoxicity marker.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Alanine Aminotransferase (ALT)
ALT level (U/L), a liver enzyme measured to monitor hepatic injury.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Interleukin-1 (IL-1)
IL-1 concentration (pg/mL), a pro-inflammatory cytokine indicative of immune and inflammatory activity.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Tumor Necrosis Factor-alpha (TNF-α)
Tumor Necrosis Factor-alpha (TNF-α) level (pg/mL) measured to assess systemic inflammation and cancer-related cachexia.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Serum Creatinine
Serum creatinine (μmol/L), measured to evaluate kidney function and treatment-related nephrotoxicity.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Blood Urea Nitrogen
Blood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Total Bilirubin
umol/LBlood urea nitrogen (umol/L), used to monitor renal function and protein catabolism.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Direct Bilirubin
Direct (conjugated) bilirubin (μmol/L), used to evaluate biliary obstruction and liver function.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Total Cholesterol
Total cholesterol level (mmol/L), measured to assess lipid metabolism and nutritional status.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Triglycerides
Serum triglyceride level (mmol/L), used to evaluate energy reserves and lipid metabolism.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
High-Density Lipoprotein Cholesterol (HDL-C)
HDL-C (mmol/L), assessed as a marker of cardiovascular health and lipid status.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Low-Density Lipoprotein Cholesterol (LDL-C)
LDL-C (mmol/L), measured as a risk factor for cardiovascular disease and lipid status.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Interleukin-6 (IL-6)
IL-6 level (pg/mL), a pro-inflammatory cytokine measured to monitor systemic inflammation and cachexia.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Hemoglobin
Hemoglobin concentration (*10⁹/L), used to assess anemia and oxygen-carrying capacity.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
White Blood Cell Count (Leukocytes)
Total white blood cell count (*10⁹/L), measured to monitor immune status and detect infection or myelosuppression.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Neutrophil Count
Absolute neutrophil count (*10⁹/L), used to assess infection risk and bone marrow suppression.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Lymphocyte Count
Lymphocyte count (*10⁹/L), measured to evaluate immune competence.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Red Blood Cell Count
Red blood cell count (*10¹²/L), used to assess erythropoiesis and anemia.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Platelet Count
Platelet count (*10⁹/L), measured to evaluate coagulation status and myelosuppression.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Height
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.
Measured: through study completion, an average of 1 year
Body Weight
Body weight (kg) measured using a calibrated scale with 0.2 kg precision. Values adjusted if ascites or edema are present.
Measured: through study completion, an average of 1 year
Body Mass Index (BMI)
BMI calculated as weight (kg) divided by height squared (m²), recorded to one decimal place.
Measured: through study completion, an average of 1 year
Change in Anxiety Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-A)
Change in Anxiety Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-A)
Measured: 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)
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).
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Functional Performance Measured by Karnofsky Performance Status (KPS)
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.
Measured: 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)
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.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Changes in Physical Activity Level During Cancer Treatment
Assessment of leisure-time physical activity levels (mild, moderate, vigorous) and their relationship with nutritional status and cancer treatment response.
Measured: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
Changes in Nutrition-Related Knowledge, Attitudes, and Practices (KAP)
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.
Measured: Baseline, 6 months, and 12 months after admission; annually up to 5 years
Healthcare Utilization and Cost of Nutrition-Related Care
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.
Measured: From admission through 30-day post-discharge and annually for 5 years
Incidence of Serious Adverse Events Related to Nutrition or Treatment
Tracking of serious adverse events potentially related to nutritional support or treatment, including infections, allergic reactions, gastrointestinal distress, and metabolic complications.
Measured: Continuously from enrollment through end of study follow-up (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start12 Nov 2020
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,538 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xiaoqin Luo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoqin Luo, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219083
- Sponsor's protocol ID
- 2022-1373
- Acronym
- NCOM
- Status last verified
- May 2026
- First submitted
- 23 Dec 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 30185853Muscaritoli 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.
PubMed 34055649Sung 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.
PubMed 33538338Xia 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.
PubMed 35143424Morgan 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.
PubMed 36604116Zhou 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.
PubMed 33707923Argiles JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. doi: 10.1016/j.ejon.2005.09.006.
PubMed 16437757Hebuterne 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.
PubMed 24748626Aaldriks AA, van der Geest LG, Giltay EJ, le Cessie S, Portielje JE, Tanis BC, Nortier JW, Maartense E. Frailty and malnutrition predictive of mortality risk in older patients with advanced colorectal cancer receiving chemotherapy. J Geriatr Oncol. 2013 Jul;4(3):218-26. doi: 10.1016/j.jgo.2013.04.001. Epub 2013 Apr 30.
PubMed 24070460Seo SH, Kim SE, Kang YK, Ryoo BY, Ryu MH, Jeong JH, Kang SS, Yang M, Lee JE, Sung MK. Association of nutritional status-related indices and chemotherapy-induced adverse events in gastric cancer patients. BMC Cancer. 2016 Nov 18;16(1):900. doi: 10.1186/s12885-016-2934-5.
PubMed 27863481Gellrich NC, Handschel J, Holtmann H, Kruskemper G. Oral cancer malnutrition impacts weight and quality of life. Nutrients. 2015 Mar 27;7(4):2145-60. doi: 10.3390/nu7042145.
PubMed 25825828Planas M, Alvarez-Hernandez J, Leon-Sanz M, Celaya-Perez S, Araujo K, Garcia de Lorenzo A; PREDyCES(R) researchers. Prevalence of hospital malnutrition in cancer patients: a sub-analysis of the PREDyCES(R) study. Support Care Cancer. 2016 Jan;24(1):429-435. doi: 10.1007/s00520-015-2813-7. Epub 2015 Jun 23.
PubMed 26099900Cong MH, Li SL, Cheng GW, Liu JY, Song CX, Deng YB, Shang WH, Yang D, Liu XH, Liu WW, Lu SY, Yu L. An Interdisciplinary Nutrition Support Team Improves Clinical and Hospitalized Outcomes of Esophageal Cancer Patients with Concurrent Chemoradiotherapy. Chin Med J (Engl). 2015 Nov 20;128(22):3003-7. doi: 10.4103/0366-6999.168963.
PubMed 26608978Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.
PubMed 33946039Tan S, Meng Q, Jiang Y, Zhuang Q, Xi Q, Xu J, Zhao J, Sui X, Wu G. Impact of oral nutritional supplements in post-discharge patients at nutritional risk following colorectal cancer surgery: A randomised clinical trial. Clin Nutr. 2021 Jan;40(1):47-53. doi: 10.1016/j.clnu.2020.05.038. Epub 2020 Jun 2.
PubMed 32563599
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Nutritional Status and Clinical Outcomes in Patients With Common Malignancies
- ClinicalTrials.gov ID
- NCT06219083
- Acronym / sponsor ID
- NCOM / 2022-1373
- Conditions
- Cancer, Chemoradiotherapy, Nutrition, Healthy, Oncology, Clinical Outcomes
- Keywords
- Chemoradiotherapy, Nutritional Status in Cancer Patients, Clinical Outcomes of Cancer Treatment, Cancer Patient Nutrition, Shaanxi Province Cancer Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,538 participants (estimated)
- Lead sponsor
- Xiaoqin LuoUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cancer patients from 20 hospitals in Shaanxi Province undergoing chemoradiotherapy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
36 secondary outcomes
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
Total Bilirubin
Time frame: 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
Total Cholesterol
Time frame: 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
High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: 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
Interleukin-6 (IL-6)
Time frame: 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
White Blood Cell Count (Leukocytes)
Time frame: 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
Lymphocyte Count
Time frame: 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
Platelet Count
Time frame: 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
Body Weight
Time frame: through study completion, an average of 1 year
Body Mass Index (BMI)
Time frame: 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 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
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
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
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
Changes in Nutrition-Related Knowledge, Attitudes, and Practices (KAP)
Time frame: 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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 30185853Baracos 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.
- Background: PubMed 34055649Muscaritoli 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.
- Results publication: PubMed 33538338Sung 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.
- Results publication: PubMed 35143424Xia 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.
- Results publication: PubMed 36604116Morgan 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.
- Results publication: PubMed 33707923Zhou 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.
- Results publication: PubMed 16437757Argiles JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. doi: 10.1016/j.ejon.2005.09.006.
- Results publication: PubMed 24748626Hebuterne 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.
- Results publication: PubMed 24070460Aaldriks AA, van der Geest LG, Giltay EJ, le Cessie S, Portielje JE, Tanis BC, Nortier JW, Maartense E. Frailty and malnutrition predictive of mortality risk in older patients with advanced colorectal cancer receiving chemotherapy. J Geriatr Oncol. 2013 Jul;4(3):218-26. doi: 10.1016/j.jgo.2013.04.001. Epub 2013 Apr 30.
- Results publication: PubMed 27863481Seo SH, Kim SE, Kang YK, Ryoo BY, Ryu MH, Jeong JH, Kang SS, Yang M, Lee JE, Sung MK. Association of nutritional status-related indices and chemotherapy-induced adverse events in gastric cancer patients. BMC Cancer. 2016 Nov 18;16(1):900. doi: 10.1186/s12885-016-2934-5.
- Results publication: PubMed 25825828Gellrich NC, Handschel J, Holtmann H, Kruskemper G. Oral cancer malnutrition impacts weight and quality of life. Nutrients. 2015 Mar 27;7(4):2145-60. doi: 10.3390/nu7042145.
- Results publication: PubMed 26099900Planas M, Alvarez-Hernandez J, Leon-Sanz M, Celaya-Perez S, Araujo K, Garcia de Lorenzo A; PREDyCES(R) researchers. Prevalence of hospital malnutrition in cancer patients: a sub-analysis of the PREDyCES(R) study. Support Care Cancer. 2016 Jan;24(1):429-435. doi: 10.1007/s00520-015-2813-7. Epub 2015 Jun 23.
- World Health Organization. Cancer. (accessed May 12, 2023)Link provided by the sponsor.
- World Health Organization. Colorectal Cancer Awareness Month 2022 - IARC n.d (accessed May 13, 2023).Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Chemoradiotherapy, run by Xiaoqin Luo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoqin Luo, Ph.D (+8617791547192, clyeah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219083, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.