Non-small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC)
Conditions
Keywords
Sarcopenia, Cachexia, Treatment-tolerance, Survival, Quality of Life, Lung cancer, Muscle function, Muscle strength, Muscle mass
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 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.
Interventions
None listed
Sponsors
Zealand University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overvall survival | 12 months from inclusion | Death from all causes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicities (DLT) | 6 months from inclusion | 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. |
| Haematological toxicities | 6 months from inclusion | Anaemia; Leukocytopenia; Neutropenia; Thrombocytopenia. Graded by the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0 |
| Change in muscle mass | 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. | Measured at the 3rd lumbar vertebrae. Routine CT-scans (from baseline CT to last performed CT) |
| Change in muscle function | 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. | 10 meter habitual and maximal gait speed (m/s) |
| Change in muscle strength | 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. | Maximal isometric handgrip strength by dynamometry |
| Health-Related Quality of Life | 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. | 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. |
| Disease-specific symptoms | 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. | 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. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORSusanne Oksbjerg Dalton, Professor
Zealand University Hospital
Outcome results
None listed