Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

Instituto Nacional de Cancerologia de Mexico

Status: Enrolling

Conditions: Quality of Life; Pulmonary Rehabilitation; Sarcopenia

Treatments: Other: Pulmonary rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02978521

016/028/ICI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Pulmonary rehabilitation

Control Group

No Intervention group

Description:

CG will receive information and recommendations on physical activity