Lung Cancer Clinical Trial
Official title:
The Impact of Changes in Respiratory Muscle Function on Dyspnea, Functional Capacity, and Quality of Life in Patients With Advanced Lung Cancer & the Effects of Chest Physiotherapy Education Intervention
The purpose for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). The 2nd phase of this study will investigate the potential beneficial effects of chest physiotherapy in the same patient population (intervention group).
Respiratory muscle function is critical for maintaining effective alveolar ventilation, and
airway secretions clearance. The reduction in respiratory muscle function might lead to
chronic respiratory insufficiency, and potentially to life-threatening problems. Respiratory
muscle function and the impacts of various treatments regimens have not been investigated
longitudinally in patients with advanced lung cancer patients.
The purposes for the 1st phase of this study are to exam longitudinal changes and the impact
of various treatments on the respiratory muscle function, and the relations with dyspnea,
functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival
status (control group). The 2nd phase of this study will investigate the potential
beneficial effects of chest physiotherapy in the same patient population (intervention
group).
Methods: 102 patients with advanced lung cancer per group will be recruited from the
National Taiwan University Hospital. Demographic and clinical signs/syndromes will be
obtained from the chart. Pain and dyspnea will be measured using visual analog scale.
Respiratory muscle strength will be tested by measuring maximal inspiratory and expiratory
pressure (PImax and PEmax, respectively). Spirometric variables, forced expiratory volume in
one second (FEV1) and forced vital capacity (FVC) will be measured. Functional capacity will
be measured using Karnofsky performance status and Simmonds functional assessment.
Anxiety/depression symptom will be measured using Hospital Anxiety and Depression Scale.
Quality of life will be measured using European Organization for Research and Treatment of
Cancer, EORTC QLQ-C30 and LC13 questionnaire. Six- and 12-month respiratory complication
morbidity and survival status will be recorded in the prospective nature.
Clinical relevance: The prevalence of lung cancer is increasing in the recent years. To
understand the indications for chest physiotherapy (e.g., respiratory muscle weakness and
its related sequels) and the effects of chest physiotherapy program will shed light on if
routine chest physiotherapy should be implanted for patients with advanced lung cancer
during treatment.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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