Clinical trial NCT06219083: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 1538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients from 20 hospitals in Shaanxi Province undergoing chemoradiotherapy.

Brief 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. 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.

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

Primary outcomes:
measure: Change in Nutritional Status Assessed by Modified Patient-Generated Subjective Global Assessment (mPG-SGA)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Change in Nutritional Risk Assessed by Nutritional Risk Screening 2002 (NRS-2002)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Change in Global Health Status Score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Change in Functional Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Change in Symptom Scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Overall Survival (OS) in Cancer Patients
timeFrame: From date of enrollment until death or last follow-up (up to 5 years)
measure: Progression-Free Survival (PFS) in Cancer Patients
timeFrame: From date of enrollment until death or last follow-up (up to 5 years)
Secondary outcomes:
measure: Serum Total Protein
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Serum Albumin
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Serum Prealbumin
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Serum Transferrin
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: C-Reactive Protein (CRP)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Blood Glucose
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Aspartate Aminotransferase (AST)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Alanine Aminotransferase (ALT)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Interleukin-1 (IL-1)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Tumor Necrosis Factor-alpha (TNF-α)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Serum Creatinine
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Blood Urea Nitrogen
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Total Bilirubin
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Direct Bilirubin
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Total Cholesterol
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Triglycerides
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Interleukin-6 (IL-6)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Hemoglobin
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: White Blood Cell Count (Leukocytes)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Neutrophil Count
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Lymphocyte Count
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Red Blood Cell Count
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Platelet Count
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Height
timeFrame: through study completion, an average of 1 year
measure: Body Weight
timeFrame: through study completion, an average of 1 year
measure: Body Mass Index (BMI)
timeFrame: through study completion, an average of 1 year
measure: Change in Anxiety Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-A)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Change in Depression Symptoms Assessed by Hospital Anxiety and Depression Scale (HADS-D)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Functional Performance Measured by Karnofsky Performance Status (KPS)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Changes in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Changes in Physical Activity Level During Cancer Treatment
timeFrame: Baseline, 1, 2, 3, 6, and 12 months after admission; annually up to 5 years
measure: Changes in Nutrition-Related Knowledge, Attitudes, and Practices (KAP)
timeFrame: Baseline, 6 months, and 12 months after admission; annually up to 5 years
measure: Healthcare Utilization and Cost of Nutrition-Related Care
timeFrame: From admission through 30-day post-discharge and annually for 5 years
measure: Incidence of Serious Adverse Events Related to Nutrition or Treatment
timeFrame: Continuously from enrollment through end of study follow-up (up to 5 years)
Other outcomes:
measure: Predictive Value of Baseline Nutritional Indicators for 30-Day Clinical Events
timeFrame: Baseline to 30 days post-admission
measure: Nutritional Trajectory Typing and Clustering
timeFrame: From baseline to 12-month follow-up
measure: Agreement Between Nutritional Screening Tools (mPG-SGA vs. NRS-2002)
timeFrame: Baseline and each scheduled follow-up visit (up to 5 years)
measure: Sociodemographic Determinants of Malnutrition
timeFrame: From baseline throughout study follow-up (up to 5 years)
measure: Patient Adherence to Out-of-Hospital Nutritional Support
timeFrame: Baseline to 12 months post-treatment initiation
Locations:
city: Xi'an
country: China
facility: Xi 'an Jiaotong University
state: Shaanxi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Argiles JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. doi: 10.1016/j.ejon.2005.09.006.
citation: 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.
citation: Aaldriks 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.
citation: Seo 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.
citation: Gellrich 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.
citation: Planas 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.
citation: Cong 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.
citation: Muscaritoli 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.
citation: Tan 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.
citation: Zietarska M, Krawczyk-Lipiec J, Kraj L, Zaucha R, Malgorzewicz S. Chemotherapy-Related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients with, or without, High Protein Nutritional Support. A Prospective, Randomized Study. Nutrients. 2017 Oct 11;9(10):1108. doi: 10.3390/nu9101108.
citation: Matthews CE, Moore SC, Arem H, Cook MB, Trabert B, Hakansson N, Larsson SC, Wolk A, Gapstur SM, Lynch BM, Milne RL, Freedman ND, Huang WY, Berrington de Gonzalez A, Kitahara CM, Linet MS, Shiroma EJ, Sandin S, Patel AV, Lee IM. Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk. J Clin Oncol. 2020 Mar 1;38(7):686-697. doi: 10.1200/JCO.19.02407. Epub 2019 Dec 26.
citation: Prabhu Das I, Baker M, Altice C, Castro KM, Brandys B, Mitchell SA. Outcomes of multidisciplinary treatment planning in US cancer care settings. Cancer. 2018 Sep 15;124(18):3656-3667. doi: 10.1002/cncr.31394. Epub 2018 Sep 14.
citation: Ruff SM, Diaz DA, Pitter KL, Hartwell BC, Pawlik TM. Multidisciplinary management in the treatment of intrahepatic cholangiocarcinoma. CA Cancer J Clin. 2023 Jul-Aug;73(4):346-352. doi: 10.3322/caac.21779. Epub 2023 Apr 12. No abstract available.
citation: Lu Z, Fang Y, Liu C, Zhang X, Xin X, He Y, Cao Y, Jiao X, Sun T, Pang Y, Wang Y, Zhou J, Qi C, Gong J, Wang X, Li J, Tang L, Shen L. Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial. J Clin Oncol. 2021 Mar 1;39(7):748-756. doi: 10.1200/JCO.20.01254. Epub 2021 Jan 8.
citation: Murphy JL, Munir F, Davey F, Miller L, Cutress R, White R, Lloyd M, Roe J, Granger C, Burden S, Turner L. The provision of nutritional advice and care for cancer patients: a UK national survey of healthcare professionals. Support Care Cancer. 2021 May;29(5):2435-2442. doi: 10.1007/s00520-020-05736-y. Epub 2020 Sep 12.
citation: Brown TE, Banks MD, Hughes BGM, Lin CY, Kenny LM, Bauer JD. Randomised controlled trial of early prophylactic feeding vs standard care in patients with head and neck cancer. Br J Cancer. 2017 Jun 27;117(1):15-24. doi: 10.1038/bjc.2017.138. Epub 2017 May 23.
citation: Ratri DMN, Hamidah KF, Puspitasari AD, Farid M. Video-based health education to support insulin therapy in diabetes mellitus patients. J Public Health Res. 2020 Jul 3;9(2):1849. doi: 10.4081/jphr.2020.1849. eCollection 2020 Jul 3.
citation: Bennell KL, Lawford BJ, Keating C, Brown C, Kasza J, Mackenzie D, Metcalf B, Kimp AJ, Egerton T, Spiers L, Proietto J, Sumithran P, Harris A, Quicke JG, Hinman RS. Comparing Video-Based, Telehealth-Delivered Exercise and Weight Loss Programs With Online Education on Outcomes of Knee Osteoarthritis : A Randomized Trial. Ann Intern Med. 2022 Feb;175(2):198-209. doi: 10.7326/M21-2388. Epub 2021 Nov 30.
citation: Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
citation: Loman BR, Luo M, Baggs GE, Mitchell DC, Nelson JL, Ziegler TR, Deutz NE, Matarese LE; NOURISH Study Group. Specialized High-Protein Oral Nutrition Supplement Improves Home Nutrient Intake of Malnourished Older Adults Without Decreasing Usual Food Intake. JPEN J Parenter Enteral Nutr. 2019 Aug;43(6):794-802. doi: 10.1002/jpen.1467. Epub 2018 Nov 22.
citation: Elia M, Normand C, Laviano A, Norman K. A systematic review of the cost and cost effectiveness of using standard oral nutritional supplements in community and care home settings. Clin Nutr. 2016 Feb;35(1):125-137. doi: 10.1016/j.clnu.2015.07.012. Epub 2015 Jul 30.
citation: Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.