Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This pilot phase I/II trial studies how well a continuous positive airway pressure device or deep inspiration breath hold works in reducing tumor movement in patients undergoing stereotactic body radiation therapy (SBRT) for lung cancer. The continuous positive airway pressure device works by blowing air into the lungs while patients wear a face mask or nozzle to help expand their airways and lungs. Deep inspiration breath hold is a standard technique that uses active breath-holding to restrict movement of the body. Using a continuous positive airway pressure device may work better than deep inspiration breath hold in lowering the amount of tumor movement during stereotactic radiation body therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncolcogy Service at MD Anderson.

Disqualifiers

The patient has a contra-indication for using a CPAP device.

The patient has not signed a study-specific informed consent for this study.

The patient is uncooperative.

The patient has reduced consciousness.

Trial design

Design model

Single group

Treatments tested in this trial

  • Biphasic Positive Airway Pressure

    Device

    Receive BiPAP

  • Computed Tomography

    Procedure/Surgery

    Undergo CT simulation scans

  • Continuous Positive Airway Pressure

    Procedure/Surgery

    Receive CPAP

  • Deep Inspiration Breath Hold

    Procedure/Surgery

    Complete DIBH

  • Radiation Therapy Treatment Planning and Simulation

    Radiation

    Undergo CT simulation scans

  • Stereotactic Body Radiation Therapy

    Radiation

    Undergo SBRT

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Estimation of decrease in tumor motion

Paired t-test will be used to compare continuous positive airway pressure (CPAP) to deep inspiration breath hold (DIBH) in the decrease of tumor motion from free breathing. Linear regression may be used to evaluate the difference between CPAP and DIBH in the decrease of tumor motion from free breathing with the adjustment of important demographic and clinical variables in the model.

Time frame
Up to 10 days

Secondary outcomes

1

Increase in lung volume

Increase in lung volume to be determined by using DIBH or CPAP from free breathing. Linear regression may be used to evaluate the difference between CPAP and DIBH in the increase of lung volume from free breathing with the adjustment of important demographic and clinical variables in the model. The study will summarize the data with mean, standard deviation, median and range for continuous variables, and frequency count and percentage for categorical variables

Time frame
Up to 10 days
2

Assessment of time to deliver the planned radiation dose by using the most appropriate method

The study will summarize the data with mean, standard deviation, median and range for continuous variables, and frequency count and percentage for categorical variables.

Time frame
Up to 10 days

Other outcomes

Sponsors and contacts

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M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator