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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03422302
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 16, 2018
Status verified
Aug 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.

Primary Outcome Measure

Estimation of decrease in tumor motion [ Time Frame: Up to 10 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Julianne M. Pollard, MD
713-563-2591
Julianne M. Pollard, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
M D Anderson Cancer Center· Houston, TX

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