RecruitingNot ApplicableNCT06688422

Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy

Incentive Spirometry for Respiratory Enhancement Pilot Clinical Trial in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy


Sponsor

The Cooper Health System

Enrollment

100 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if using an incentive spirometer can reduce lung problems in people with advanced lung cancer who are receiving chemotherapy and radiation therapy. The main questions the study aims to answer are: Does using an incentive spirometer lower the chances of developing lung inflammation (pneumonitis)? Does it improve overall survival and quality of life? Participants will: Use an incentive spirometer, a device that helps with deep breathing, 10 times every hour while awake. Continue using the spirometer daily during treatment and for up to three months after treatment. Complete quality of life assessments at the start of the study and at 3, 6, and 12 months. Researchers will compare the results to see if the incentive spirometer helps reduce lung problems and improves participants\' well-being during and after their cancer treatment.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Confirmed diagnosis of advanced non-small-cell lung cancer
  • Performance status (ECOG 0-1)
  • Eligible for concurrent chemotherapy and radiation
  • years or older

Exclusion Criteria8

  • Previous lung or thoracic surgery
  • Enrollment in another pulmonary intervention trial
  • Home oxygen usage prior to enrolment
  • Radiological evidence of pleural effusion, pneumothorax, bullous emphysema, - or pneumonitis on staging imaging
  • Presence of active respiratory tract infection
  • Uncontrolled nausea and vomiting
  • Prior exposure to drugs such as amiodarone, bleomycin, or immunotherapy
  • Inability or unwillingness of individual to give written informed consent

Interventions

DEVICEincentive spirometry

The study will have one intervention group of patients using incentive spirometry in addition to standard of care treatment, including chemo/radiation and immunotherapy maintenance. Patients will use the incentive spirometer 10 times (10 breaths) every hour they are awake. Patients will be asked to start using the incentive spirometer as soon as they are enrolled in the study. Patients will be asked to continue to use incentive spirometry daily, including the duration of chemoradiation and up to three months post-treatment.


Locations(1)

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

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NCT06688422


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