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

NCT06219083 | Recruiting

• 1 other identifier: 2022-1373
• Study Type: observational
• Target: 1,538
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  From date of enrollment until death or last follow-up (up to 5 years)

Secondary Outcomes (36)

• Serum Total Protein

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

• Serum Albumin

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

• Serum Prealbumin

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

• Serum Transferrin

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

• C-Reactive Protein (CRP)

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

Other Outcomes (5)

• Predictive Value of Baseline Nutritional Indicators for 30-Day Clinical Events

  Baseline to 30 days post-admission

• Nutritional Trajectory Typing and Clustering

  From baseline to 12-month follow-up

• Agreement Between Nutritional Screening Tools (mPG-SGA vs. NRS-2002)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients from 20 hospitals in Shaanxi Province undergoing chemoradiotherapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiaoqin Luo: lead

Study Sites (1)

Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (28)

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• 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.

  PMID: 34055649 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.

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• 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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• 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.

  PMID: 24748626 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.

  PMID: 24070460 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.

  PMID: 27863481 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.

  PMID: 25825828 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.

  PMID: 26099900 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.

  PMID: 26608978 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.

  PMID: 33946039 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.

  PMID: 32563599 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.

  PMID: 29019951 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.

  PMID: 31877085 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.

  PMID: 30216477 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.

  PMID: 37046405 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.

  PMID: 33417481 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.

  PMID: 32918612 RESULT

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• 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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• 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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• 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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• 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.

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Related Links

• World Health Organization. Cancer. (accessed May 12, 2023)
• World Health Organization. Colorectal Cancer Awareness Month 2022 - IARC n.d (accessed May 13, 2023).

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue, paracancerous tissue, Serum, Fecal samples

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Xiaoqin Luo, Ph.D

CONTACT

+8617791547192; clyeah@hotmail.com

Hexiang Yang, Ph.D

CONTACT

+8617782582639; 592518222@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 23, 2024
• Study Start: November 12, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available after the publication of the main study results, anticipated to be by the end of 2025. The data will be accessible for a period of five years following this date.
• Access Criteria: Researchers interested in accessing the data will be required to submit a proposal outlining their intended use of the data, which will be reviewed by the study's principal investigator. Access will be granted based on the scientific merit and ethical considerations of the proposal.

Locations

CN (1)