Nutritional Status and Clinical Outcomes in Patients With Common Malignancies(NCOM)
NCT ID: NCT06219083
Last Updated: 2025-06-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
1538 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-11-12
Study Completion Date
2031-12-01
Brief Summary
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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.
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Detailed Description
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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.
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
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Cancer
Chemoradiotherapy
Nutrition, Healthy
Oncology
Clinical Outcomes
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Xiaoqin Luo
OTHER
Sponsor Role
lead
Responsible Party
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Xiaoqin Luo
Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Locations
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Xi 'an Jiaotong University
Xi'an, Shaanxi, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
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RESULT
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.
Reference Type
RESULT
Argiles JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. doi: 10.1016/j.ejon.2005.09.006.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
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RESULT
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.
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RESULT
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.
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RESULT
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.
Reference Type
RESULT
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.
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RESULT
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RESULT
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.
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RESULT
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.
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RESULT
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.
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RESULT
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.
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RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
https://www.who.int/news-room/fact-sheets/detail/cancer
World Health Organization. Cancer. (accessed May 12, 2023)
https://www.iarc.who.int/featured-news/colorectal-cancer-awareness-month-2022/
World Health Organization. Colorectal Cancer Awareness Month 2022 - IARC n.d (accessed May 13, 2023).
Other Identifiers
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2022-1373
Identifier Type: -
Identifier Source: org_study_id
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