Clinical trial NCT06730685: Sarcopenia and Cachexia in Patients with Lung Cancer
Official title: PHILUCA: the Development of Muscle Mass, Muscle Strength, and Muscle Function in Patients with Lung Cancer During Cancer Treatment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Non-small Cell Lung Cancer (NSCLC)
Small Cell Lung Cancer (SCLC)
Keywords: Sarcopenia
Cachexia
Treatment-tolerance
Survival
Quality of Life
Lung cancer
Muscle function
Muscle strength
Muscle mass
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed and treated at Zealand University Hospital, Naestved Hospital

Brief 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. 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 (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.

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

Primary outcomes:
measure: Overvall survival
timeFrame: 12 months from inclusion
Secondary outcomes:
measure: Chemotherapy completion rate
timeFrame: 6 months from inclusion
measure: Dose-limiting toxicities (DLT)
timeFrame: 6 months from inclusion
measure: Haematological toxicities
timeFrame: 6 months from inclusion
measure: Non-haematological toxicities
timeFrame: 6 months from inclusion
measure: Change in muscle mass
timeFrame: 12 months from inclusion
measure: Change in muscle function
timeFrame: 6 months from inclusion
measure: Change in muscle function
timeFrame: 6 months from inclusion
measure: Change in muscle strength
timeFrame: 6 months from inclusion
measure: Health-Related Quality of Life
timeFrame: 3 and 6 months from inclusion
measure: Disease-specific symptoms
timeFrame: 3 and 6 months from inclusion
Other outcomes:
Locations:
city: Naestved
country: Denmark
facility: Zealand University Hospital
state: Region Zealand
Study officials:
affiliation: Zealand University Hospital
name: Susanne Oksbjerg Dalton, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.