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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To compare the two methods of tumor motion management, continuous positive airway pressure (CPAP) and deep inspiration breath hold (DIBH) and to estimate the decrease in tumor motion from free breathing for CPAP and DIBH.

SECONDARY OBJECTIVES:

I. To determine if CPAP is a more time-efficient option for tumor motion management than is DIBH.

Ia. Determine if CPAP is better tolerated by patients than is DIBH. Ib. Determine the reproducibility of lung expansion and tumor motion reduction by CPAP.

Ic. Determine if the dosimetric coverage of the tumor and the sparing of the normal tissues with CPAP is comparable to that with DIBH.

Id. Measure treatment time differences between CPAP and breath hold (DIBH) treatments.

OUTLINE:

Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo biphasic positive airway pressure (BiPAP) CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes.

Conditions

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Lung Carcinoma Malignant Respiratory Tract Neoplasm Metastatic Malignant Neoplasm in the Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP)

Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergo BiPAP CT simulation. The attending physician then compares all 3 simulation treatment plans (free-breathing, DIBH, and CPAP/BiPAP) and determines which method to use during SBRT. If CPAP/BiPAP is chosen as preferred method, patients wear CPAP/BiPAP over 1 hour prior to SBRT, then again during SBRT over 30-60 minutes. All other patients complete free-breathing or DIBH during SBRT over 30-60 minutes.

Group Type EXPERIMENTAL

Biphasic Positive Airway Pressure

Intervention Type DEVICE

Receive BiPAP

Computed Tomography

Intervention Type PROCEDURE

Undergo CT simulation scans

Continuous Positive Airway Pressure

Intervention Type PROCEDURE

Receive CPAP

Deep Inspiration Breath Hold

Intervention Type PROCEDURE

Complete DIBH

Radiation Therapy Treatment Planning and Simulation

Intervention Type RADIATION

Undergo CT simulation scans

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Undergo SBRT

Interventions

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Biphasic Positive Airway Pressure

Receive BiPAP

Intervention Type DEVICE

Computed Tomography

Undergo CT simulation scans

Intervention Type PROCEDURE

Continuous Positive Airway Pressure

Receive CPAP

Intervention Type PROCEDURE

Deep Inspiration Breath Hold

Complete DIBH

Intervention Type PROCEDURE

Radiation Therapy Treatment Planning and Simulation

Undergo CT simulation scans

Intervention Type RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Intervention Type RADIATION

Other Intervention Names

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BiPAP Biphasic positive airway pressure (BiPAP) CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT SCAN tomography Continuous positive airway pressure (CPAP) CPAP DIBH Radiation Therapy Treatment Planning/Simulation SABR SBRT Stereotactic Ablative Body Radiation Therapy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
* The patient has sustained trauma or burns to the face.
* The patient has undergone any facial, esophageal, gastric or sinus surgery within the last 3 months.
* The patient has idiopathic pulmonary fibrosis (IPF) as documented in their medical history.
* Adults who are unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No