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

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 94 participants

Interventions

• OTHER: Pulmonary 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

Primary Outcomes

• Pulmonary function (After 12 sessions (6 weeks))

Secondary Outcomes

• Muscle mass (After 12 sessions (6 weeks))
• Inflammatory response (After 12 sessions (6 weeks))
• Exercise tolerance (After 12 sessions (6 weeks))
• 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).)
• Lung Cancer Quality of Life (After 12 sessions (6 weeks))

Eligibility Criteria

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

Trial Locations

• Instituto Nacional de Cancerología, Mexico City, Mexico City, Mexico

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