Malnutrition and Sarcopenia Screening in Chemotherapy Patients

NCT07163286 | Active Not Recruiting

• 1 other identifier: COMU-FNO-3
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study will include approximately 150 adult outpatients diagnosed with solid tumors who are currently receiving chemotherapy. Both early and advanced stage patients of any sex aged 18 and older will be included, provided they are clinically stable and able to participate in the assessments.

Conditions

Nutrition Aspect of Cancer; Sarcopenia; Chemotherapeutic Agent Toxicity

Outcome Measures

Primary Outcomes (2)

• PG-SGA short form values

  From enrollment to 6 month

• Nutriscore

  From enrollment to 6 month

Study Arms (1)

1

The study will include approximately 150 adult outpatients diagnosed with solid tumors who are currently receiving chemotherapy. Both early and advanced stage patients of any sex aged 18 and older will be included, provided they are clinically stable and able to participate in the assessments.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include approximately 150 adult outpatients (≥18 years) diagnosed with solid tumors (e.g., breast, lung, gastrointestinal, gynecologic cancers) who are currently receiving chemotherapy. Participants must have undergone or be scheduled for an abdominal CT scan within the last 3 months and must be physically and mentally capable of completing the assessments. Hospitalized patients and those with hematologic malignancies will be excluded.

You may qualify if:

• Age ≥ 18 years
• Diagnosed with a solid tumor (e.g., breast, lung, GI, gynecologic cancers)
• Receiving active outpatient chemotherapy
• Recent abdominal CT scan within the last 3 months or planned
• Provided written informed consent
• Physically and mentally able to complete study procedures

You may not qualify if:

• Declined or unable to give informed consent
• Cognitive impairment or mental status preventing participation
• Neuromuscular diseases affecting muscle mass (e.g., myopathy, MND, severe neuropathy)
• Inadequate CT image quality for L3 analysis
• Acute infection or illness within the past month
• Upper limb deformity or severe pain preventing handgrip testing
• Incomplete assessments or withdrawal of consent during the study

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, 17020, Turkey (Türkiye)

Location

Related Publications (11)

• Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25.

  PMID: 23530101 BACKGROUND

• Bellanti F, Lo Buglio A, Quiete S, Pellegrino G, Dobrakowski M, Kasperczyk A, Kasperczyk S, Vendemiale G. Comparison of Three Nutritional Screening Tools with the New Glim Criteria for Malnutrition and Association with Sarcopenia in Hospitalized Older Patients. J Clin Med. 2020 Jun 17;9(6):1898. doi: 10.3390/jcm9061898.

  PMID: 32560480 BACKGROUND

• Trujillo EB, Kadakia KC, Thomson C, Zhang FF, Livinski A, Pollard K, Mattox T, Tucker A, Williams V, Walsh D, Clinton S, Grossberg A, Jensen G, Levin R, Mills J, Singh A, Smith M, Stubbins R, Wiley K, Sullivan K, Platek M, Spees CK. Malnutrition risk screening in adult oncology outpatients: An ASPEN systematic review and clinical recommendations. JPEN J Parenter Enteral Nutr. 2024 Nov;48(8):874-894. doi: 10.1002/jpen.2688. Epub 2024 Oct 16.

  PMID: 39412097 BACKGROUND

• Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.

  PMID: 30181091 BACKGROUND

• Arribas L, Hurtos L, Sendros MJ, Peiro I, Salleras N, Fort E, Sanchez-Migallon JM. NUTRISCORE: A new nutritional screening tool for oncological outpatients. Nutrition. 2017 Jan;33:297-303. doi: 10.1016/j.nut.2016.07.015. Epub 2016 Aug 13.

  PMID: 27751743 BACKGROUND

• Cho JW, Youn J, Kim EM, Choi MG, Lee JE. Associations of patient-generated subjective global assessment (PG-SGA) and NUTRISCORE with survival in gastric cancer patients: timing matters, a retrospective cohort study. BMC Gastroenterol. 2022 Nov 17;22(1):468. doi: 10.1186/s12876-022-02515-3.

  PMID: 36396994 BACKGROUND

• Baracos VE, Martin L, Korc M, Guttridge DC, Fearon KCH. Cancer-associated cachexia. Nat Rev Dis Primers. 2018 Jan 18;4:17105. doi: 10.1038/nrdp.2017.105.

  PMID: 29345251 BACKGROUND

• Lee JS, Kim YS, Kim EY, Jin W. Prognostic significance of CT-determined sarcopenia in patients with advanced gastric cancer. PLoS One. 2018 Aug 20;13(8):e0202700. doi: 10.1371/journal.pone.0202700. eCollection 2018.

  PMID: 30125312 BACKGROUND

• 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 BACKGROUND

• Pressoir M, Desne S, Berchery D, Rossignol G, Poiree B, Meslier M, Traversier S, Vittot M, Simon M, Gekiere JP, Meuric J, Serot F, Falewee MN, Rodrigues I, Senesse P, Vasson MP, Chelle F, Maget B, Antoun S, Bachmann P. Prevalence, risk factors and clinical implications of malnutrition in French Comprehensive Cancer Centres. Br J Cancer. 2010 Mar 16;102(6):966-71. doi: 10.1038/sj.bjc.6605578. Epub 2010 Feb 16.

  PMID: 20160725 BACKGROUND

• Bullock AF, Patterson MJ, Paton LW, Currow DC, Johnson MJ. Malnutrition, sarcopenia and cachexia: exploring prevalence, overlap, and perceptions in older adults with cancer. Eur J Clin Nutr. 2024 Jun;78(6):486-493. doi: 10.1038/s41430-024-01433-9. Epub 2024 Apr 5.

  PMID: 38580728 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncology Fellowship Dr.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: September 9, 2025
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-05

Locations

TU (1)