Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

Study Overview
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Brief Summary
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Lung cancer (LC) is usually diagnosed in advanced stages and continues to be the leading cause of cancer related deaths worldwide. Cancer cachexia are frequent among patients with LC affecting up to 80% of patients with advanced stage disease, and it has been related with higher risk of complications, length of hospital stay, and worst overall survival. During cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass has been associated to higher treatment related toxicity, loss of functional status, shorter progression free survival and overall survival in different types of cancer under various treatments. Hence, preservation of muscle mass and function should be an important focus of the multidisciplinary treatment of patients with LC. Pulmonary rehabilitation (PR) has been known to improve pulmonary function, reduce fatigue and improve exercise tolerance in patients with LC undergoing curative surgery. However, few studies have focused on the efficacy of PR on patients with advanced cancer undergoing palliative care with chemotherapy or targeted therapies.

Detailed Description
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The main objective of this study is to determine the effects of a pulmonary rehabilitation program on the pulmonary function and muscle mass. Moreover, the effects on exercise tolerance, inflammatory response, quality of live and overall survival will be explored. Patients will be randomized into intervention group (IG) or control group (CG). Patients in the IG will be scheduled to receive 12 sessions of PR over a period of 4-6 weeks (2-3 session/week). CG will receive information and recommendations on physical activity. Both groups will receive nutritional assessment and intervention as needed.

Official Title
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Effect of a Pulmonary Rehabilitation Program on Skeletal Muscle Mass, Pulmonary Function, Inflammatory Response and Overall Survival on Patients Diagnosed With Non-small-cell Advanced Cancer

Conditions
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Pulmonary Rehabilitation, Sarcopenia, Quality of Life

Intervention / Treatment
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* Other: Pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of advanced non-small-cell lung cancer Good performance status (ECOG 0-1) Life expectancy >12 weeks Eligible to receive treatment with chemotherapy or tyrosinkinase inhibitors Recent electrocardiogram without evidence of arrythmia Exclusion Criteria: Symptomatic brain metastasis Uncontrolled pain (Visual Analog Scale >5) Uncontrolled hypertension (>140/100mmHg) Practice of regular moderate to intense physical activity at least 3 day/week Not residents of Mexico City or unable to attend to therapy sessions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patients in the IG will be scheduled to receive Pulmonary Rehabilitation: 12 sessions (60 minutes approximately) over a period of 4-6 weeks (2-3 session/week). Sessions will progress as patients tolerance to exercise and will include breathing techniques, resistance training on ergometer and treadmill. | Other: Pulmonary rehabilitation<br>* Session 1: ventilatory pattern training Session 2,3: ventilatory pattern + respiratory training with incentive spirometer Session 4-6: Sessions 1-3 training continues + training with Positive expiratory pressure device (Threshold PEP) and breathing trainer Threshold IMT) Sessions 7-9: Continue respiratory training + resistance training with RECK MOTOmed2 ergometer at a 30% intensity until 60% is achieved Session 10-12: Continue with previous training + treadmill training<br>|
| No Intervention: Control Group<br>CG will receive information and recommendations on physical activity | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function | Pulmonary function Maximal expiratory and inspiratory pressure units: cm H2O (measured with Jaeger spirometer) | After 12 sessions (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass | Muscle mass measured by body composition analysis of CT images using lumbar vertebra 3 (L3) | After 12 sessions (6 weeks) | 
| Inflammatory response | Quantification of: Interleukin (IL)-8, IL-1β, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF) (Human Inflammatory Cytokine Kit Becton, Dickinson and Company (BD)™ Cytometric Bead Array) Units: pg/ml | After 12 sessions (6 weeks) | 
| Exercise tolerance | 6 minute walk test | After 12 sessions (6 weeks) | 
| Quality of Life in lung cancer | To determine the Quality of Life (QoL) of patients with lung cancer and its association with rehabilitation. Application of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire, the EORTC QLQ-C30. It is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. It ranges in score from 0 to 100. A high scale score represents a higher response level. | the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire is applied before and after a follow-up after 12 sessions (6 weeks). | 
| Lung Cancer Quality of Life | Application of the european organization for research and treatment of cancer quality of life questionnaire (QLQ)LC-13 | After 12 sessions (6 weeks) | 
| Anxiety and Depression | Hospital Anxiety and Depression Scale (HADS | After 12 sessions (6 weeks) |