Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstituto Nacional de Cancerologia de Mexico
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary rehabilitation
Other interventionSession 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
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pulmonary function
Pulmonary function Maximal expiratory and inspiratory pressure units: cm H2O (measured with Jaeger spirometer)
Time frame
After 12 sessions (6 weeks)Secondary outcomes
1
Muscle mass
Muscle mass measured by body composition analysis of CT images using lumbar vertebra 3 (L3)
Time frame
After 12 sessions (6 weeks)2
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
Time frame
After 12 sessions (6 weeks)3
Exercise tolerance
6 minute walk test
Time frame
After 12 sessions (6 weeks)4
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.
Time frame
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).Sponsors and contacts
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Source ClinicalTrials.gov