CPAP or Deep Inspiration Breath Hold for Lung Cancer

Overseen By Julianne M. Pollard, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Reduced consciousness, Facial trauma, IPF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 10 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to reduce lung tumor movement during radiation therapy. One method uses a continuous positive airway pressure (CPAP) device, which keeps airways open by blowing air into the lungs. The other method involves deep inspiration breath hold, where patients take a deep breath and hold it to help keep the body still. The trial seeks patients receiving stereotactic body radiation therapy (a precise form of radiation treatment) for lung cancer who can use a CPAP device without issues. Participants will help researchers determine which method more effectively reduces tumor movement during treatment. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future radiation therapy techniques.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these methods are safe for reducing tumor movement during SBRT?

Research has shown that continuous positive airway pressure (CPAP) can increase lung size and reduce tumor movement during treatment. However, one study raised safety concerns about using CPAP during certain lung cancer procedures, which is important to consider when evaluating treatment options.

In contrast, deep inspiration breath hold (DIBH) is considered safe and effective. Studies have found that it improves lung positioning and reduces radiation exposure to healthy tissues. DIBH also stabilizes the tumor during treatment, offering a significant benefit.

Both CPAP and DIBH have their own safety considerations. While CPAP may present some risks, it can be beneficial in specific situations. DIBH is generally regarded as a safe option with positive outcomes for lung cancer patients. It is crucial to weigh the pros and cons and consult healthcare providers to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative breathing techniques to improve the precision of Stereotactic Body Radiation Therapy (SBRT) for lung cancer. Unlike standard care that typically uses free-breathing during radiation, this trial investigates the potential benefits of Continuous Positive Airway Pressure (CPAP) and Deep Inspiration Breath Hold (DIBH) techniques. These methods aim to minimize lung movement and enhance the accuracy of radiation delivery, potentially leading to better outcomes and fewer side effects for patients. By comparing these techniques, researchers hope to identify the most effective way to stabilize the lungs during treatment, offering a more personalized approach to lung cancer care.

What evidence suggests that these methods are effective for reducing tumor movement in lung cancer?

This trial will compare continuous positive airway pressure (CPAP) and deep inspiration breath hold (DIBH) during stereotactic body radiation therapy (SBRT) for lung cancer. Studies have shown that CPAP can control tumor movement during radiation therapy by increasing lung size, which reduces tumor movement. In some cases, CPAP increased lung size by 35%, potentially reducing radiation exposure to nearby healthy tissues. Meanwhile, DIBH effectively reduces radiation to the heart and keeps the lungs expanded to limit tumor movement. Both CPAP and DIBH show promise in reducing tumor movement during lung cancer treatment, though they operate differently. Participants in this trial will undergo CT simulation scans with both methods to determine the most effective approach for their treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Julianne M. Pollard

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for lung cancer patients who will receive thoracic SBRT at MD Anderson and have a CT-visible tumor. It's not for those with reduced consciousness, contraindications to CPAP use, no consent given, uncooperative behavior, recent facial or upper body surgery, or idiopathic pulmonary fibrosis.

Inclusion Criteria

My lung cancer or its spread to the lung is visible on a CT scan.

I will get a specific type of radiation therapy at MD Anderson.

Exclusion Criteria

I am experiencing periods of reduced consciousness.

The patient has not signed a study-specific informed consent for this study.

The patient is uncooperative.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

CT Simulation

Patients undergo free-breathing, DIBH, and CPAP CT simulation scans. If patient has difficulty exhaling on CPAP, then patient undergoes BiPAP CT simulation.

1 day

1 visit (in-person)

Treatment

Patients receive SBRT using the chosen method (CPAP/BiPAP or DIBH) over 30-60 minutes.

Up to 10 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biphasic Positive Airway Pressure
• Computed Tomography
• Continuous Positive Airway Pressure
• Deep Inspiration Breath Hold
• Radiation Therapy Treatment Planning and Simulation
• Stereotactic Body Radiation Therapy

Trial Overview The study compares the effectiveness of a CPAP device versus deep inspiration breath hold in reducing tumor movement during lung cancer treatment with SBRT. The goal is to see if CPAP can better restrict tumor motion than the standard breath-holding technique.

How Is the Trial Designed?

Group I: Treatment (CT simulation, CPAP, DIBH, SBRT, BiPAP) Experimental Treatment 6 Interventions

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.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Stereotactic ablative radiation therapy (SABR) for lung oligometastases shows promising safety and efficacy, with a 24-month overall survival rate of 74.6% and minimal toxicity, as only one significant adverse event was reported among 77 patients studied over an average follow-up of 22 months.

Colorectal metastases exhibited a notably higher local failure rate compared to other types of tumors, suggesting they may be more resistant to SABR, indicating a need for potential dose escalation strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. Binkley, MS., Trakul, N., Jacobs, LR., et al.[2022]

Stereotactic ablative radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).

Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]

A collaborative program for implementing stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer (NSCLC) across multiple centers in New South Wales has been successfully established, demonstrating a safe and efficient approach to treatment.

In a study involving 41 patients, the early toxicity profile of SABR was consistent with existing literature, and there was no significant impact on quality of life, indicating that SABR can be a viable treatment option for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative implementation of stereotactic ablative body radiotherapy: A model for the safe implementation of complex radiotherapy techniques in Australia. Hau, E., Hegi-Johnson, F., Atkinson, C., et al.[2020]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9454671/

Efficacy and Optimal Pressure of Continuous Positive ... In a study of patients with left breast cancer, CPAP increased the lung volume by 35% and decreased the mean dose of the heart and ipsilateral ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9790747/

Cancer Risk Associated with Continuous Positive Airway ... We found that 200 of the 209 reported cancer cases associated with CPAP devices were received by the FDA in the first 9 months of 2021, which means that more ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824000612

Continuous and bilevel positive airway pressure may ... CPAP might reduce tumor motion by applying a constant positive airway pressure, resulting in increased lung volumes, more diaphragm flattening and consequently ...

4. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-024-01721-9

Continuous positive airway pressure is unsafe for ... This study highlights the hazards of continuous positive airway pressure during radiofrequency ablation of lung cancer, even at minimal pressures.

5. redjournal.org redjournal.org/article/S0360-3016(21)00306-0/abstract

Benefits of Continuous Positive Airway Pressure (CPAP) ... This study aimed to study the impact of continuous positive airway pressure (CPAP) on chest anatomy and tumor motion in patients receiving ...

6. redjournal.org redjournal.org/article/S0360-3016(19)31267-2/fulltext

Benefits of Continuous Positive Airway Pressure (CPAP) in ... CPAP significantly increases lung volume, reduces tumor motion, distancing the heart from the chest wall, and reduces radiation exposure to normal tissues.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35352830/

Cancer Risk Associated with Continuous Positive Airway ... Of the 209 cancer cases associated with CPAP, 200 (95.7%) of the adverse event reports were received by the FDA in 2021. There were 174 (9.15%) ...