Clinical trial NCT02978521: Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Rehabilitation
Sarcopenia
Quality of Life
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pulmonary function
timeFrame: After 12 sessions (6 weeks)
Secondary outcomes:
measure: Muscle mass
timeFrame: After 12 sessions (6 weeks)
measure: Inflammatory response
timeFrame: After 12 sessions (6 weeks)
measure: Exercise tolerance
timeFrame: After 12 sessions (6 weeks)
measure: Quality of Life in lung cancer
timeFrame: 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).
measure: Lung Cancer Quality of Life
timeFrame: After 12 sessions (6 weeks)
measure: Anxiety and Depression
timeFrame: After 12 sessions (6 weeks)
Other outcomes:
Locations:
city: Mexico Distrito Federal
country: Mexico
facility: Instituto Nacional de Cancerología
Study officials:
affiliation: Head of Thoracic Oncology Unit
name: Oscar Arrieta
role: STUDY_DIRECTOR
References:
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