CPAP Devices for Breast and Lung Cancer

Overseen By Sheeh Cherian, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Right side breast cancer, CPAP intolerance

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how CPAP devices (machines that assist with breathing) can aid patients with certain types of cancer during radiation therapy. It specifically targets individuals with left-sided breast cancer and those receiving specialized lung radiation treatment. Participants will use CPAP during their scans to determine if it improves treatment outcomes. Suitable candidates include patients with left-sided breast cancer undergoing radiation or those with primary or metastatic lung tumors receiving radiation therapy. As an unphased trial, this study provides patients an opportunity to contribute to innovative research that could enhance cancer treatment outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that CPAP devices are safe for patients with breast and lung cancer?

Research shows that continuous positive airway pressure (CPAP) can help manage various health conditions and is generally well-tolerated by patients. Studies have found that CPAP can increase lung capacity and reduce tumor movement during radiation therapy, protecting healthy tissues from excessive radiation.

While CPAP primarily treats sleep apnea, it also benefits cancer treatments by minimizing radiation impact on healthy tissues. Rare reports have linked CPAP to cancer cases, but no solid evidence indicates that CPAP itself is a risk factor.

Overall, CPAP is considered safe for medical use, especially since the FDA has approved it for treating sleep-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CPAP devices for treating breast and lung cancer because these devices could improve the precision and effectiveness of radiation therapy. Unlike standard radiation treatment, which can be affected by a patient’s breathing motion, CPAP uses continuous positive airway pressure to stabilize breathing. This stability allows for more accurate targeting of tumors during radiation, potentially sparing healthy tissue and enhancing treatment outcomes. By integrating CPAP, there's hope for reduced side effects and improved quality of life for patients undergoing radiation therapy.

What evidence suggests that CPAP devices are effective for breast and lung cancer?

Research has shown that Continuous Positive Airway Pressure (CPAP) during radiation therapy benefits patients with left-sided breast cancer and those undergoing lung stereotactic body radiation therapy (SBRT). This trial will divide participants into separate arms to evaluate the effects of CPAP and Deep Inspiration Breath Hold (DIBH) during treatment. Studies have found that CPAP increases lung size and reduces tumor movement, allowing for more precise targeting during treatment. For left-sided breast cancer, CPAP significantly lowers the radiation dose to the heart and nearby arteries, reducing potential side effects. In lung cancer treatments, CPAP reduces the radiation exposure to the lungs, which may help protect healthy lung tissue. Overall, CPAP-assisted radiotherapy has improved treatment results and is considered a promising approach for these types of cancer. ^{2 4 6 7 8}

Who Is on the Research Team?

Sheeh Cherian, MD

Principal Investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with left-sided breast cancer or those undergoing lung SBRT, including cases of metastatic and primary lung cancers. It's not suitable for individuals with right-side breast cancer or those who cannot tolerate a CPAP device.

Inclusion Criteria

My cancer originated in my lungs.

I am receiving radiation therapy on my left breast or chest wall, possibly including nearby lymph nodes.

I am receiving targeted radiation therapy for my lung.

Exclusion Criteria

My breast cancer is in the right breast.

You cannot use the CPAP machine without difficulty.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Planning and Treatment

Participants undergo radiation planning and treatment with CPAP, including three scans (with and without DIBH, with CPAP).

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of lung and cardiac dosimetry.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Positive Airway Pressure
• Deep inspiratory breath hold
• Free Breath

Trial Overview The study is evaluating the use of CPAP devices during radiation therapy to see if they can reduce the amount of radiation received by the lungs in patients with certain types of breast and lung cancers.

How Is the Trial Designed?

Group I: Lung SBRT Active Control 3 Interventions

Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.

Group II: left-sided breast cancer Active Control 3 Interventions

Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

The lightweight CPAP delivery device effectively increases oxygen levels in patients during one-lung ventilation, with peripheral oxygen saturation improving while CPAP levels ranged from 2.8 to 5.4 cmH2O in a clinical study involving seven patients.

The device's CPAP output is directly proportional to the oxygen flow rate and is not affected by the compliance or resistance of the lung, allowing for predictable CPAP levels before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple, lightweight CPAP-delivery device, composed of a three-way stopcock, for the nondependent lung. Sasano, H., Sasano, N., Ito, S., et al.[2021]

In a study of 9,317 patients with obstructive sleep apnea (OSA) treated with CPAP, there was a significant reduction in overall mortality compared to 18,370 matched control subjects, with a hazard ratio of 0.67, indicating a 33% lower risk of death.

The lower mortality rate in CPAP-treated patients was primarily linked to a reduction in cancer-related deaths, while no significant impact was observed on cardiovascular-related deaths, highlighting the need to consider sex differences in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Analysis of Causes of Mortality in Continuous Positive Airway Pressure-treated Patients at the Population Level. de Batlle, J., Bertran, S., Turino, C., et al.[2021]

In a study of 8261 patients with suspected obstructive sleep apnea (OSA), those with lung cancer had a significantly higher incidence of cancer compared to the general population, indicating a potential link between OSA and increased cancer risk.

The study found that cancer-related mortality in lung cancer patients increased with the severity of OSA, with a 3-year mortality rate of 80% for those with severe OSA (AHI ≥ 30), while patients with milder OSA (AHI < 30) had better overall and progression-free survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Obstructive Sleep Apnea Associated With Higher Risk of Mortality in Stage III and IV Lung Cancer. Huang, HY., Shih-Wei, L., Chuang, LP., et al.[2020]

Patients with obstructive sleep apnoea treated with continuous positive airway pressure (CPAP) have high survival rates, with 96% surviving at 3 years and 93% at 5 years, comparable to the general population.

Survival is negatively impacted by factors such as heavy smoking history, low lung function (measured by FEV1), and high pulmonary artery pressure, particularly in patients aged 50-60 years, especially those with chronic obstructive pulmonary disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of lung function and pulmonary haemodynamics in OSA patients treated with CPAP. Chaouat, A., Weitzenblum, E., Krieger, J., et al.[2019]

In a study of 64 postoperative lung cancer patients, those using continuous positive airway pressure (CPAP) showed significant improvements in blood gas analysis and airway patency compared to those receiving standard oxygen therapy.

One month after treatment, CPAP patients experienced fewer symptoms such as inappetence, weight loss, and dyspnea, and demonstrated better lung function metrics like higher maximum ventilatory volumes and peak expiratory flows, indicating its efficacy in enhancing recovery post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing postoperative lung cancer patients using continuous positive airway pressure treatment. Jiang, Q., Zheng, W., Chen, B.[2021]

In a study of 4,499 patients with obstructive sleep apnoea (OSA) followed for an average of 5.4 years, adherence to continuous positive airway pressure (CPAP) therapy did not significantly reduce the overall incidence of cancer compared to nonadherent patients.

Out of the participants, 10.7% of nonadherent patients developed cancer, while 9.1% of adherent patients did, indicating that CPAP adherence did not have a measurable impact on cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer risk in patients with sleep apnoea following adherent 5-year CPAP therapy. Justeau, G., Bailly, S., Gervès-Pinquié, C., et al.[2022]

In a study of 25,389 patients with obstructive sleep apnea (OSA), continuous positive airway pressure (CPAP) treatment was linked to a significant reduction in all-cause mortality in middle-aged and elderly males, with a hazard ratio of 0.62 (P<0.001).

While CPAP improved survival rates in older males, it did not show a significant effect on mortality in female patients, indicating a gender difference in the efficacy of CPAP treatment for OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All-cause mortality from obstructive sleep apnea in male and female patients with and without continuous positive airway pressure treatment: a registry study with 10 years of follow-up. Jennum, P., Tønnesen, P., Ibsen, R., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32143658/

CPAP (Continuous Positive Airway Pressure) Is an ... Conclusion: CPAP assisted radiotherapy was tolerable and produced superior treatment plans in left sided breast cancer. This method is worthy of ...

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

Efficacy and Optimal Pressure of Continuous Positive ... CPAP linearly increased lung volume and decreased the dosimetric parameter in the pressure range 7 to 13 cmH2O (p < 0.01). Above 13 cmH2O, V5 of ...

3. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-020-01505-7

CPAP (Continuous Positive Airway Pressure) is an effective ... They demonstrated significant differences in decrease of tumor motion as well as the increase of total lung volume and decrease in both lung and ...

4. aapm.onlinelibrary.wiley.com aapm.onlinelibrary.wiley.com/doi/10.1002/acm2.70284

Integrating surface‐guided radiation therapy and continuous ... This study demonstrates that SGRT, with or without CPAP, provides effective surface displacement management during breast cancer radiation ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424000356

Continuous Positive Airway Pressure–Assisted Breathing ... 01). Compared with FB, both DIBH and CPAP significantly reduced radiation dose to the heart and LAD. A mean dose to the heart (HeartDmean) ...

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

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%) descriptions of ...

7. 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.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725002424

Self-reported witnessed episodes of apnea during sleep is ... Self-reported witnessed apneas during sleep was associated with breast cancer in women in the multivariable analysis aHR, 1.39 (95 %CI 1.05, 1.84) p = 0.023, ...