CPAP versus deep inspiration breath hold to reduce lung tumor motion during SBRT
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
This test compares whether a CPAP breathing device or holding a deep breath better reduces tumor movement during SBRT for people with lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03422302 on ClinicalTrials.gov |
What this trial studies
This pilot Phase I/II trial compares continuous positive airway pressure (CPAP) and deep inspiration breath hold (DIBH) as methods to reduce tumor motion during stereotactic body radiation therapy (SBRT). Patients receive CT simulation scans during free breathing, DIBH, and CPAP (with BiPAP if CPAP exhalation is difficult), and physicians generate and compare treatment plans from each method. If CPAP/BiPAP is chosen, patients wear the device before and during SBRT; otherwise they are treated with DIBH or free breathing. Secondary measures include time efficiency, patient tolerance, reproducibility of lung expansion and motion reduction, and dosimetric effects on tumor coverage and normal tissue sparing.
Who should consider this trial
Good fit: Adults with lung tumors scheduled to receive SBRT at MD Anderson who can consent and are able to tolerate CPAP or DIBH are ideal candidates.
Not a fit: Patients with contraindications to CPAP/BiPAP (recent facial surgery, facial trauma or burns), idiopathic pulmonary fibrosis, inability to cooperate or consent, pregnant women, and prisoners are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could reduce tumor motion during SBRT, allowing tighter treatment margins and potentially less radiation to healthy lung tissue.
How similar studies have performed: DIBH is an established technique for motion control, while use of CPAP for reducing lung tumor motion has only limited pilot data and is less well tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Julianne M Pollard — M.D. Anderson Cancer Center
- Study coordinator: Julianne M. Pollard, PHD
- Email: JMPollard@mdanderson.org
- Phone: 713-563-2591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.