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Non-small Cell Lung Cancer (NSCLC)PHILUCANCT06730685

Sarcopenia and Cachexia in Patients With Lung Cancer

An observational study of Non-small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC), run by Zealand University Hospital at 1 site in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
160 participants
Where
1 siteDenmark
Study dates
12 Dec 2024to 1 Apr 2028
How long will I take part?
12 Months
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: Patients who have been diagnosed and treated at Zealand University Hospital, Naestved Hospital

Who may be able to join

  • Age ≥ 18 years of age
  • Diagnosed with lung cancer (all types and stages) and scheduled for oncological treatment
  • More than 3 months expected survival

Who cannot join

  • Competing cancer
  • Pregnancy
  • Severe physical or cognitive disabilities preventing physical testing and informend consent
  • Not able to read and understand Danish

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark1 site

  • Zealand University Hospital

    Næstved, Region Sjælland, 4700

Other trials in Denmark

About this study

Official title: PHILUCA: The Development of Muscle Mass, Muscle Strength, and Muscle Function in Patients With Lung Cancer During Cancer Treatment

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.

Read the 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.

Keywords
Sarcopenia, Cachexia, Treatment-tolerance, Survival, Quality of Life, Lung cancer, Muscle function, Muscle strength, Muscle mass
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Sarcopenia, Cachexia, Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overvall survival

    Death from all causes

    Measured: 12 months from inclusion

Secondary outcomes (8)

  1. Dose-limiting toxicities (DLT)

    DLT defined as switching treatment; treatment delay (≥3 days from initially planned); treatment de-escalation (dose reduction ≥15% of platinum agent); early treatment termination; and hospitalization ≥1 day, all due to chemotherapy-induced side effects.

    Measured: 6 months from inclusion

  2. Haematological toxicities

    Anaemia; Leukocytopenia; Neutropenia; Thrombocytopenia. Graded by the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0

    Measured: 6 months from inclusion

  3. Change in muscle mass

    Measured at the 3rd lumbar vertebrae. Routine CT-scans (from baseline CT to last performed CT)

    Measured: 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.

  4. Change in muscle function

    10 meter habitual and maximal gait speed (m/s)

    Measured: 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.

  5. Change in muscle function

    30-second sit to stand (5 x times sit to stand measured concurrently)

    Measured: 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.

  6. Change in muscle strength

    Maximal isometric handgrip strength by dynamometry

    Measured: 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.

  7. Health-Related Quality of Life

    Measured by the EORTC Questionnaire Core 30 (QLQ-C30). The QLQ-C30 questionnaire consists of 30 questions with five functional scales (physical, role, cognitive, emotional and social), three symptom scales, a global health status / QoL scale, and six single items.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: 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.

  8. Disease-specific symptoms

    Measured by the EORTC lung module (QLQ-LC13). The QLQ-LC13 module comprises both multi-item and single-item measures of lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (hair loss,neuropathy, sore mouth and dysphagia).

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start12 Dec 2024
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
160 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730685
Sponsor's protocol ID
PHILUCA
Other IDs
SJ-1081
Acronym
PHILUCA
Status last verified
Feb 2026
First submitted
6 Dec 2024
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For statistical analyses all data will be transferred to the Danish Cancer Institute

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 18.

    PubMed 35301821

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC), run by Zealand University Hospital at 1 site in Denmark.

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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 12 Feb 2026. 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 Denmark. 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?

Overvall survival (time frame: 12 months from inclusion). 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 NCT06730685, which also lists 7 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 12 Feb 2026.

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