Pulmonary Rehabilitation, Quality of Life, Sarcopenia
Conditions
Brief summary
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
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.
Interventions
OTHERPulmonary rehabilitation
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
Sponsors
Instituto Nacional de Cancerologia de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function | After 12 sessions (6 weeks) | Pulmonary function Maximal expiratory and inspiratory pressure units: cm H2O (measured with Jaeger spirometer) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass | After 12 sessions (6 weeks) | Muscle mass measured by body composition analysis of CT images using lumbar vertebra 3 (L3) |
| Inflammatory response | After 12 sessions (6 weeks) | 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 |
| Exercise tolerance | After 12 sessions (6 weeks) | 6 minute walk test |
| Quality of Life in lung cancer | 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). | 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. |
| Lung Cancer Quality of Life | After 12 sessions (6 weeks) | Application of the "european organization for research and treatment of cancer quality of life questionnaire (QLQ)LC-13" |
| Anxiety and Depression | After 12 sessions (6 weeks) | Hospital Anxiety and Depression Scale (HADS |
Countries
Mexico
Contacts
CONTACTOscar Arrieta
CONTACTDiana Flores
STUDY_DIRECTOROscar Arrieta
Head of Thoracic Oncology Unit
Outcome results
None listed