Sarcopenia and Cachexia in Patients With Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PHILUCA: The Development of Muscle Mass, Muscle Strength, and Muscle Function in Patients With Lung Cancer During Cancer Treatment
Overview
The PHILICA study investigates whether muscle mass, muscle strength, and muscle function are associated with treatment tolerance, quality of life and survival in patients with lung cancer. It also aims to explore why some patients face challenges in completing their treatment. The findings may contribute to improved strategies for supporting patients and developing more precise and individualized treatment plans in the future.
Detailed description
The PHILUCA prospective cohort study investigates the relationship between sarcopenia, cachexia, and change in muscle parameters with both treatment tolerance, quality of life and survival in patients with lung cancer receiving systemic treatment(s) (n=160). It aims to identify factors associated with difficulties in completing oncological treatment and to elucidate patterns that may inform improved patient support and individualized treatment planning. The study involves non-invasive physical assessments, patient-reported questionnaires, and the analysis of routinely collected medical data.
Assessments of muscle mass, muscle strength, muscle function, and quality of life are conducted at key time points, including at diagnosis and after three months into treatment or until the first control scan. Physical tests are performed during routine hospital visits, requiring no additional appointments. Body composition analysis is performed using Bioelectrical impedance analysis and by Computed Tomography scans obtained as part of standard care, without additional imaging procedures.
All participants receive standard lung cancer treatment, which may include surgery, chemotherapy, radiation therapy, immunotherapy, targeted therapy, or combinations thereof, based on disease type and stage. The study does not interfere with or modify standard care protocols. Participants unwilling or unable to fully participate may still contribute by completing a baseline questionnaire and consenting to the use of medical record data.
The study seeks to advance the understanding of how muscle-related parameters influence cancer treatment outcomes. The findings are anticipated to inform strategies for optimizing treatment tolerance, improving patient outcomes, and tailoring supportive care interventions for individuals with lung cancer.
Primary outcome measures
- Overvall survival [Time frame: 12 months from inclusion]
Secondary outcome measures (8)
- Dose-limiting toxicities (DLT) [Time frame: 6 months from inclusion]
- Haematological toxicities [Time frame: 6 months from inclusion]
- Change in muscle mass [Time frame: Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.]
- Change in muscle function [Time frame: Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.]
- Change in muscle function [Time frame: Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.]
- Change in muscle strength [Time frame: Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.]
- Health-Related Quality of Life [Time frame: Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.]
- Disease-specific symptoms [Time frame: Assessments are intended to be performed around 3 months after inclusion, which in routine clinical practice usually corresponds to the time point immediately before the first control scan.]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years of age
- Diagnosed with lung cancer (all types and stages) and scheduled for oncological treatment
- More than 3 months expected survival
Exclusion criteria
- Competing cancer
- Pregnancy
- Severe physical or cognitive disabilities preventing physical testing and informend consent
- Not able to read and understand Danish
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Zealand University Hospital — Næstved
Publications
- Sayer AA, Cooper R, Arai H, Cawthon PM, Ntsama Essomba MJ, Fielding RA, Grounds MD, Witham MD, Cruz-Jentoft AJ. Sarcopenia. Nat Rev Dis Primers. 2024 Sep 19;10(1):68. doi: 10.1038/s41572-024-00550-w. PMID 39300120
- Dalton SO, Steding-Jessen M, Jakobsen E, Mellemgaard A, Osterlind K, Schuz J, Johansen C. Socioeconomic position and survival after lung cancer: Influence of stage, treatment and comorbidity among Danish patients with lung cancer diagnosed in 2004-2010. Acta Oncol. 2015 May;54(5):797-804. doi: 10.3109/0284186X.2014.1001037. Epub 2015 Mar 12. PMID 25761702
- Buentzel J, Heinz J, Bleckmann A, Bauer C, Rover C, Bohnenberger H, Saha S, Hinterthaner M, Baraki H, Kutschka I, Emmert A. Sarcopenia as Prognostic Factor in Lung Cancer Patients: A Systematic Review and Meta-analysis. Anticancer Res. 2019 Sep;39(9):4603-4612. doi: 10.21873/anticanres.13640. PMID 31519557
- Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4. PMID 21296615
- Srdic D, Plestina S, Sverko-Peternac A, Nikolac N, Simundic AM, Samarzija M. Cancer cachexia, sarcopenia and biochemical markers in patients with advanced non-small cell lung cancer-chemotherapy toxicity and prognostic value. Support Care Cancer. 2016 Nov;24(11):4495-502. doi: 10.1007/s00520-016-3287-y. Epub 2016 May 28. PMID 27236439
- Sjoblom B, Gronberg BH, Benth JS, Baracos VE, Flotten O, Hjermstad MJ, Aass N, Jordhoy M. Low muscle mass is associated with chemotherapy-induced haematological toxicity in advanced non-small cell lung cancer. Lung Cancer. 2015 Oct;90(1):85-91. doi: 10.1016/j.lungcan.2015.07.001. Epub 2015 Jul 9. PMID 26198373
- de Jong C, Chargi N, Herder GJM, van Haarlem SWA, van der Meer F, van Lindert ASR, Ten Heuvel A, Brouwer J, de Jong PA, Devriese LA, Huitema ADR, Egberts TCG, de Bree R, Deneer VHM. The association between skeletal muscle measures and chemotherapy-induced toxicity in non-small cell lung cancer patients. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1554-1564. doi: 10.1002/jcsm.12967. Epub 2022 Mar PMID 35301821
Identifiers
NCT: NCT06730685 · PHILUCA · SJ-1081