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Enrolling by Invitation

NCT Number: NCT06730685

Sarcopenia and Cachexia in Patients With Lung Cancer

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.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Atrophy Body Weight Body Weight Changes Bronchial Neoplasms Cachexia Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcopenia Signs and Symptoms Small Cell Lung Cancer (SCLC) Small Cell Lung Carcinoma Thinness Thoracic Neoplasms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zealand University Hospital

Næstved, Region Sjælland, 4700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overvall survival

    Time frame: 12 months from inclusion

    Death from all causes

Secondary outcomes

  1. Dose-limiting toxicities (DLT)

    Time frame: 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.

  2. Haematological toxicities

    Time frame: 6 months from inclusion

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

    Maximal isometric handgrip strength by dynamometry

  7. 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.

    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.

  8. 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.

    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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Acronym: PHILUCA

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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