Actively Recruiting
Measuring the Effectiveness of a Continuous Positive Airway Pressure Device to Reduce Tumor Motion and Increase Lung Volume Expansion in Patients Undergoing Stereotactic Body Radiotherapy for Tumors That Move With Respiration
Led by M.D. Anderson Cancer Center · Updated on 2026-01-27
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well two different methods—continuous positive airway pressure (CPAP) and deep inspiration breath hold (DIBH)—reduce tumor movement during stereotactic body radiation therapy (SBRT) for patients with lung cancer. This pilot phase I/II trial aims to compare these techniques to see which is better at limiting tumor motion and expanding lung volume, potentially improving radiation targeting. The study also seeks to find out if CPAP is more time-efficient and better tolerated by patients than DIBH. Participants undergo CT simulation scans using free-breathing, DIBH, and CPAP methods. If a patient has difficulty exhaling with CPAP, a biphasic positive airway pressure (BiPAP) simulation is done. The physician then selects the best method for SBRT. If CPAP or BiPAP is preferred, patients wear the device for over one hour before and during the 30-60 minute radiation treatment. Otherwise, patients complete radiation using free-breathing or DIBH techniques over the same time frame. During the study, patients receive various scans and radiation treatments to measure tumor movement and lung volume changes. Researchers monitor treatment time, patient tolerance, and how well normal tissues are spared during therapy. The primary outcome is the decrease in tumor motion measured within 10 days. Secondary outcomes include lung volume increase and radiation delivery time. Participants are observed throughout the treatment, with detailed assessments to evaluate the effectiveness of each tumor motion management method.
CONDITIONS
Brief Title
Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncology Service at MD Anderson.
You will not qualify if you...
- The patient has a contraindication 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 10 days
Participants undergo CT simulation scans using free-breathing, deep inspiration breath hold (DIBH), and continuous positive airway pressure (CPAP). If participants have difficulty exhaling on CPAP, they undergo biphasic positive airway pressure (BiPAP) CT simulation instead. The best method for radiation treatment is then determined.
1 to 2 visits depending on simulation needs
Duration - Up to 10 days
Participants receive stereotactic body radiation therapy (SBRT) using the selected tumor motion management method. Those assigned to CPAP/BiPAP wear the device for over 1 hour prior to SBRT and again during SBRT for 30 to 60 minutes. Participants using free-breathing or DIBH complete SBRT over 30 to 60 minutes.
1 treatment period with device use as applicable
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Julianne M. Pollard, PHD
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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