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Recruiting NCT03422302

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

No phase Interventional Lung Carcinoma Malignant Respiratory Tract Neoplasm Metastatic Malignant Neoplasm in the Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biphasic Positive Airway Pressure, Computed Tomography, Continuous Positive Airway Pressure, Deep Inspiration Breath Hold.
Who it may be relevant to
Registry conditions: Lung Carcinoma, Malignant Respiratory Tract Neoplasm, Metastatic Malignant Neoplasm in the Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Measuring the Effectiveness of a Continuous Positive Airway Pressure (CPAP) Device to Reduce Tumor Motion and Increase Lung Volume Expansion in Patients Undergoing Stereotactic Body Radiotherapy (SBRT) for Tumors That Move With Respiration

Overview

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.

Detailed description

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.

Interventions

  • Device Biphasic Positive Airway Pressure
    Receive BiPAP
  • Procedure Computed Tomography
    Undergo CT simulation scans
  • Procedure Continuous Positive Airway Pressure
    Receive CPAP
  • Procedure Deep Inspiration Breath Hold
    Complete DIBH
  • Radiation Radiation Therapy Treatment Planning and Simulation
    Undergo CT simulation scans
  • Radiation Stereotactic Body Radiation Therapy
    Undergo SBRT

Primary outcome measures

  • Estimation of decrease in tumor motion [Time frame: Up to 10 days]
Secondary outcome measures (2)
  • Increase in lung volume [Time frame: Up to 10 days]
  • Assessment of time to deliver the planned radiation dose by using the most appropriate method [Time frame: Up to 10 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT03422302 · 2016-1105 · NCI-2018-00884 · 2016-1105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗