Sarcopenia and Cachexia in Patients with Lung Cancer

• Conditions: Non-small Cell Lung Cancer (NSCLC); Small Cell Lung Cancer (SCLC)

• Registration Number: NCT06730685
• Lead Sponsor: Zealand University 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-11
• Study Start: 2024-12-12
• Study First Posted: 2024-12-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-11-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overvall survival	12 months from inclusion	Death from all causes

Secondary Outcome Measures

Name	Time	Method
Chemotherapy completion rate	6 months from inclusion	Relative Dose Intensity in %
Dose-limiting toxicities (DLT)	6 months from inclusion	DLT defined as switching treatment (cisplatin to carboplatin); treatment delay (≥7 days from initially planned); treatment de-escalation (dose reduction ≥25% 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
Non-haematological toxicities	6 months from inclusion	Nephrotoxicity; Neurotoxicity; Esophagitis. Graded by the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Change in muscle mass	12 months from inclusion	Measured at the 3rd lumbar vertebrae. Routine CT-scans (from baseline CT to last performed CT)
Change in muscle function	6 months from inclusion	30-second sit to stand (5 x times sit to stand measured concurrently)
Change in muscle strength	6 months from inclusion	Maximal isometric handgrip strength by dynamometry
Health-Related Quality of Life	3 and 6 months from inclusion	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	3 and 6 months from inclusion	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.

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Naestved, Region Zealand, Denmark