Sarcopenia and Cachexia in Patients with Lung Cancer

NCT ID: NCT06730685

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-12

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 (n=180). 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, three months, and six months into treatment. For patients undergoing chemotherapy, muscle strength- and function tests are - in addition to the planned assessments - also performed before each treatment cycle, but no later than six months after the diagnosis. Physical tests are performed during routine hospital visits, requiring no additional appointments. Body composition analysis is performed using 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small Cell Lung Cancer (NSCLC) Small Cell Lung Cancer (SCLC)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Sarcopenia Cachexia Treatment-tolerance Survival Quality of Life Lung cancer Muscle function Muscle strength Muscle mass

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susanne Dalton

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susanne Oksbjerg Dalton, Professor

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zealand University Hospital

Næstved, Region Sjælland, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 39300120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25761702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31519557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21296615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27236439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26198373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35301821 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SJ-1081

Identifier Type: OTHER

Identifier Source: secondary_id

PHILUCA

Identifier Type: -

Identifier Source: org_study_id