Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06688422

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

Led by The Cooper Health System · Updated on 2026-04-15

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

The Cooper Health System

Lead Sponsor

T

The Cooper Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether using an incentive spirometer can reduce lung complications in people with advanced non-small-cell lung cancer who are receiving chemotherapy and radiation therapy together. The study aims to find out if this device lowers the chances of lung inflammation called pneumonitis and if it improves overall survival and quality of life. This pilot study focuses on patients eligible for combined chemo and radiation treatment with immunotherapy maintenance. Participants will use an incentive spirometer, a device that encourages deep breathing, by taking 10 breaths every hour while awake. They will start using the device as soon as they join the study and continue daily through their chemoradiation treatment phase (about 6 to 8 weeks) and for up to three months after treatment ends. The study involves one group receiving this intervention alongside their standard cancer care. During the study, participants will complete quality of life questionnaires and undergo pulmonary function tests at the start and at 3, 6, and 12 months after treatment. Researchers will monitor adherence to the spirometry routine through patient logs and check-ins. The main outcome measured is the incidence of pneumonitis over 12 months, along with the severity of pneumonitis and overall survival. The total participation time is approximately one year, including follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of advanced non-small-cell lung cancer
  • Performance status (ECOG 0-1)
  • Eligible for concurrent chemotherapy and radiation
  • 18 years or older
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 6 to 8 weeks

Participants use an incentive spirometer to encourage deep breathing and lung expansion, starting as soon as they enroll. This is done in addition to standard chemotherapy, radiation therapy, and immunotherapy maintenance.

Daily use of the spirometer 10 times every hour while awake during concurrent chemoradiation

Implementation

Duration - Up to 3 months post-treatment

Participants continue using the incentive spirometer daily after chemoradiation treatment to support respiratory function.

Daily use of the spirometer 10 times every hour while awake

Follow-up

Duration - Up to 12 months post-treatment

Participants complete quality of life assessments and pulmonary function tests to monitor outcomes after treatment and spirometry use.

Assessments at 3, 6, and 12 months post-treatment

Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States, 08103

Actively Recruiting

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Research Team

V

Veli Bakalov, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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Published Research Related To This Trial

Symptomatic Pneumonitis With Durvalumab After Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC.

Johan F Vansteenkiste, Jarushka Naidoo, Corinne Faivre-Finn...

https://pubmed.ncbi.nlm.nih.gov/38455595