Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

January 31, 2024 updated by: Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Oscar Arrieta
  • Phone Number: 71113 01 55 56280400

Study Contact Backup

  • Name: Diana Flores
  • Phone Number: 71113 01 55 56280400

Study Locations

  • Mexico
      • Mexico Distrito Federal, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerologia
        • Contact:
          • Diana Flores
          • Phone Number: 71113 01 55 56280400
        • Contact:
          • Oscar Arrieta, M.D.; M.Sc
          • Phone Number: 71113 01 55 56280400
        • Principal Investigator:
          • Martha de la Torre, M. Sc
        • Sub-Investigator:
          • Julissa Luvián, M. Sc
        • Sub-Investigator:
          • Richard Alcantar, PT
        • Sub-Investigator:
          • Karina Gallo, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

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.
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
No Intervention: Control Group
CG will receive information and recommendations on physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function
Time Frame: After 12 sessions (6 weeks)
Pulmonary function Maximal expiratory and inspiratory pressure units: cm H2O (measured with Jaeger spirometer)
After 12 sessions (6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass
Time Frame: After 12 sessions (6 weeks)
Muscle mass measured by body composition analysis of CT images using lumbar vertebra 3 (L3)
After 12 sessions (6 weeks)
Inflammatory response
Time Frame: 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
After 12 sessions (6 weeks)
Exercise tolerance
Time Frame: After 12 sessions (6 weeks)
6 minute walk test
After 12 sessions (6 weeks)
Lung Cancer Quality of Life
Time Frame: After 12 sessions (6 weeks)
Application of the "european organization for research and treatment of cancer quality of life questionnaire (QLQ)LC-13"
After 12 sessions (6 weeks)
Anxiety and Depression
Time Frame: After 12 sessions (6 weeks)
Hospital Anxiety and Depression Scale (HADS
After 12 sessions (6 weeks)
Quality of Life in lung cancer
Time Frame: 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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Study Director: Oscar Arrieta, Head of Thoracic Oncology Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2016

Primary Completion (Estimated)

August 5, 2024

Study Completion (Estimated)

December 12, 2025

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimated)

December 1, 2016

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 016/028/ICI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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