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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Continue using the spirometer daily during treatment and for up to three months after treatment."
  • "Secondary endpoints include evaluating the impact on overall survival and patients\' quality of life using the EORTC QLQ-C30 questionnaire."
  • "The use will continue daily during chemoradiation and up to three months post-treatment."
  • "The study duration for each subject is approximately six months, including the use of incentive spirometry during the concurrent chemoRT phase (6-8 weeks) and continued use for up to three months post-treatment."
  • "Patients will be asked to continue to use incentive spirometry daily, including the duration of chemoradiation and up to three months post-treatment."
  • "Continued use of the spirometer for up to three months post-treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a deep-breathing device can reduce lung inflammation, help people live longer, and improve quality of life. It is for adults with advanced non-small-cell lung cancer who will get chemotherapy and radiation at the same time. Participants use the device 10 times each hour while awake during treatment and for up to 3 months after treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of advanced non-small-cell lung cancer.
  • Be fully active or able to do light work despite some limits on hard physical activity (ECOG 0–1).
  • Be able to receive chemotherapy and radiation at the same time.
  • Be age 18 or older.

Who can't join

  • Have had lung or chest surgery.
  • Are in another study testing a lung treatment.
  • Used oxygen at home before joining the study.
  • Have scans showing fluid around a lung, a collapsed lung, emphysema with large air pockets, or lung inflammation.
  • Have an active infection in the airways or lungs.
  • Have nausea and vomiting that are not controlled.
  • Have previously received drugs such as amiodarone, bleomycin, or immunotherapy (treatment that uses the immune system).
  • Are unable or unwilling to give written consent to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Confirmed diagnosis of advanced non-small-cell lung cancer * Performance status (ECOG 0-1) * Eligible for concurrent chemotherapy and radiation * 18 years or older Exclusion Criteria: * 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

Study sites (1)

NJ