Advanced NSCLC Clinical Trial
Official title:
Physical Exercise Program in Lung Cancer Patients With Non-operable Disease Undergoing Palliative Treatment
The investigators plan to evaluate, in a randomized, controlled phase III trial in patients
with advanced non-small cell lung cancer (NSCLC), the effects of a 24-week exercise
intervention program (EIP) on quality of life, physical functioning and immune function
parameters. Eligible patients (n=250) will be enrolled in the Clinic for Thoracic Diseases,
Heidelberg, over a time period of two years and followed up for a total of 12 months.
Patients will be randomized either to EIP plus Care Management Phone Calls (CMPC) versus CMPC
alone (besides a proper symptom and side effect management CMPC ensures the potential
influence of social contacts that can be anticipated for the patients in the intervention
group).
Our primary aims are to investigate whether a combination of a partly supervised (in- and
outpatient) and partly home-based endurance and resistance training improves quality of life
(QoL) and lowers levels of fatigue (evaluation via the standardized and validated
questionnaires FACT-L and MFI). In addition we propose to evaluate the effects of EIP on
tumor specific immune responses. Biomarkers of immune function will be measured by cellular
immunity and cytokine and chemokine panels.
Further secondary outcomes include measurement of anxiety, depression and demoralization,
physical performance parameters (e.g. improvement in walk distance, muscle strength), as well
as overall and progression free survival analyses.
The study builds on a previous feasibility study of a 8 weeks exercise intervention trial in
patients with advanced NSCLC with the results being utilized in the design of the here
proposed trial.
The investigators hypothesize that patients randomized in the exercise intervention group
will show improved QoL and reduced fatigue, as well as improved physical functioning and
increased tumor specific immune responses.
n/a
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