Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

Not Applicable

Recruiting

• Conditions: Pulmonary Rehabilitation; Quality of Life; Sarcopenia
• Interventions: Other: Pulmonary rehabilitation

• Registration Number: NCT02978521
• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico

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.

Study Timeline

• Study Start: 2016-08-05
• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-12-05
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Pulmonary rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Pulmonary function	After 12 sessions (6 weeks)	Pulmonary function Maximal expiratory and inspiratory pressure units: cm H2O (measured with Jaeger spirometer)

Secondary Outcome Measures

Name	Time	Method
Exercise tolerance	After 12 sessions (6 weeks)	6 minute walk test
Muscle mass	After 12 sessions (6 weeks)	Muscle mass measured by body composition analysis of CT images using lumbar vertebra 3 (L3)
Anxiety and Depression	After 12 sessions (6 weeks)	Hospital Anxiety and Depression Scale (HADS
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
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"

Trial Locations

Locations (1)

Instituto Nacional de Cancerología; 🇲🇽 Mexico Distrito Federal, Mexico