Nutrition Aspect of CancerNCT07163286
Malnutrition and Sarcopenia Screening in Chemotherapy Patients
An observational study of Nutrition Aspect of Cancer and Sarcopenia, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Aspect of Cancer, Sarcopenia, Chemotherapeutic Agent Toxicity
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çanakkale Onsekiz Mart University
Çanakkale, 17020
About this study
Official title: Evaluation and Comparison of Malnutrition and Sarcopenia Risk Using PG-SGA, MUST, Nutriscore, and GLIM Criteria in Cancer Patients Undergoing Chemotherapy
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.
Read the detailed description
Background: Malnutrition and sarcopenia are prevalent and clinically significant conditions in cancer patients receiving chemotherapy. Accurate nutritional screening and early diagnosis of sarcopenia are critical for improving treatment outcomes and quality of life. Several screening tools are used for nutritional risk assessment in oncology, including PG-SGA, MUST, Nutriscore, and the recently proposed GLIM criteria.
Objective: This cross-sectional study aims to evaluate the risk of malnutrition and sarcopenia in solid tumor outpatients receiving chemotherapy. It compares the effectiveness and correlation of PG-SGA, MUST, Nutriscore, and GLIM criteria, and investigates their association with sarcopenia, measured via handgrip strength and CT-based skeletal muscle index at the L3 level.
Methods: Approximately 150 adult cancer patients receiving active outpatient chemotherapy will be assessed. Nutritional status will be evaluated using PG-SGA, MUST, Nutriscore, and GLIM. Sarcopenia will be determined via handgrip strength testing and analysis of CT images. Charlson Comorbidity Index will be used to assess comorbidity burden.
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PG-SGA short form values
Measured: From enrollment to 6 month
Nutriscore
Measured: From enrollment to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Jul 2025
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Nutrition Aspect of 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Eroğlu, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163286
- Sponsor's protocol ID
- COMU-FNO-3
- Status last verified
- May 2025
- First submitted
- 31 Jul 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23530101Bellanti 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.
PubMed 32560480Trujillo 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.
PubMed 39412097Cederholm 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.
PubMed 30181091Arribas 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.
PubMed 27751743Cho 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.
PubMed 36396994Baracos 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.
PubMed 29345251Lee 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.
PubMed 30125312Hebuterne 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 24748626Pressoir 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.
PubMed 20160725Bullock 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.
PubMed 38580728
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of Malnutrition and Sarcopenia Risk Using PG-SGA, MUST, Nutriscore, and GLIM Criteria in Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07163286
- Acronym / sponsor ID
- COMU-FNO-3
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 9 Sep 2025 (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.
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.
Detailed description
Background: Malnutrition and sarcopenia are prevalent and clinically significant conditions in cancer patients receiving chemotherapy. Accurate nutritional screening and early diagnosis of sarcopenia are critical for improving treatment outcomes and quality of life. Several screening tools are used for nutritional risk assessment in oncology, including PG-SGA, MUST, Nutriscore, and the recently proposed GLIM criteria.
Objective: This cross-sectional study aims to evaluate the risk of malnutrition and sarcopenia in solid tumor outpatients receiving chemotherapy. It compares the effectiveness and correlation of PG-SGA, MUST, Nutriscore, and GLIM criteria, and investigates their association with sarcopenia, measured via handgrip strength and CT-based skeletal muscle index at the L3 level.
Methods: Approximately 150 adult cancer patients receiving active outpatient chemotherapy will be assessed. Nutritional status will be evaluated using PG-SGA, MUST, Nutriscore, and GLIM. Sarcopenia will be determined via handgrip strength testing and analysis of CT images. Charlson Comorbidity Index will be used to assess comorbidity burden.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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
PG-SGA short form values
Time frame: From enrollment to 6 month
Nutriscore
Time frame: From enrollment to 6 month
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 9 Sep 2025.
- Background: PubMed 23530101Martin 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.
- Background: PubMed 32560480Bellanti 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.
- Background: PubMed 39412097Trujillo 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.
- Background: PubMed 30181091Cederholm 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.
- Background: PubMed 27751743Arribas 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.
- Background: PubMed 36396994Cho 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.
- Background: PubMed 29345251Baracos 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.
- Background: PubMed 30125312Lee 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.
- Background: 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.
- Background: PubMed 20160725Pressoir 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.
- Background: PubMed 38580728Bullock 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Nutrition Aspect of Cancer and Sarcopenia, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
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 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PG-SGA short form values (time frame: From enrollment to 6 month). The study lists 2 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 NCT07163286, which also lists 11 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 9 Sep 2025.